Pub Date : 2024-09-16DOI: 10.1101/2024.09.13.24313618
Eleonora Benhar, Agathe van Lamsweerde, Elina Berglund Scherwitzl, Kerry Krauss, Raoul Scherwitzl
Objective This study aimed to investigate the key demographics and evaluate the real-world contraceptive failure and continuation rates of the Natural Cycles app in a cohort of women from Canada. Methods This was a real-world, prospective cohort study. Demographics were assessed via in-app questionnaires. Contraceptive failure rates in typical and perfect use were calculated using the 13-cycle cumulative pregnancy probability (Kaplan-Meier survival analysis) and the one-year Pearl Index (PI). One-year continuation rates were estimated through survival analysis. Results The study included 8 '798 women who contributed an average of 9.2 months of data, amounting to a total of 7' 063 woman-years of exposure. The average user was 27.3 years old, had a body mass index of 24.6, and reported being in a stable relationship. With typical use, the app demonstrated a 13-cycle cumulative pregnancy probability of 4.8 [95% CI: 4.3, 5.4] and a Pearl Index of 4.3 [95% CI: 3.9, 4.8]. Under perfect use, the contraceptive failure rate was 2.3 [95% CI: 0.7, 3.9] for life table analysis and 1.7 [95% CI: 0.5, 2.8] for the 1-year PI. The contraceptive method's continuation rate after one year was 62.4%. Conclusions The data presented in this study offer valuable insights into the cohort of women using the Natural Cycles app in Canada and provide country-specific effectiveness estimates. The app's contraceptive effectiveness aligns with previously published data on Natural Cycles.
{"title":"Contraceptive Outcomes of the Natural Cycles Birth Control App: A Study of Canadian Women","authors":"Eleonora Benhar, Agathe van Lamsweerde, Elina Berglund Scherwitzl, Kerry Krauss, Raoul Scherwitzl","doi":"10.1101/2024.09.13.24313618","DOIUrl":"https://doi.org/10.1101/2024.09.13.24313618","url":null,"abstract":"Objective This study aimed to investigate the key demographics and evaluate the real-world contraceptive failure and continuation rates of the Natural Cycles app in a cohort of women from Canada. Methods This was a real-world, prospective cohort study. Demographics were assessed via in-app questionnaires. Contraceptive failure rates in typical and perfect use were calculated using the 13-cycle cumulative pregnancy probability (Kaplan-Meier survival analysis) and the one-year Pearl Index (PI). One-year continuation rates were estimated through survival analysis. Results\u0000The study included 8 '798 women who contributed an average of 9.2 months of data, amounting to a total of 7' 063 woman-years of exposure. The average user was 27.3 years old, had a body mass index of 24.6, and reported being in a stable relationship. With typical use, the app demonstrated a 13-cycle cumulative pregnancy probability of 4.8 [95% CI: 4.3, 5.4] and a Pearl Index of 4.3 [95% CI: 3.9, 4.8]. Under perfect use, the contraceptive failure rate was 2.3 [95% CI: 0.7, 3.9] for life table analysis and 1.7 [95% CI: 0.5, 2.8] for the 1-year PI. The contraceptive method's continuation rate after one year was 62.4%. Conclusions\u0000The data presented in this study offer valuable insights into the cohort of women using the Natural Cycles app in Canada and provide country-specific effectiveness estimates. The app's contraceptive effectiveness aligns with previously published data on Natural Cycles.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1101/2024.09.11.24313496
Herbert Kayiga, Emelie Looft-Trägårdh, Amanda Cleeve, Othman Kakaire, Nazarius Mbona Tumwesigye, Musa Sekikubo, Joseph Rujumba, Kristina Gemzell-Danielsson, Josaphat Byamugisha
Background: Although intrauterine devices (IUDs) are readily available in Uganda, their utilization remains low, including within post abortion care. The level and factors associated with uptake of post abortion IUDs are not well documented. We set out to determine the uptake and factors associated with uptake of post abortion IUDs after medical management of first trimester incomplete abortions in central Uganda. Methods: Between February 2023 and September 2023, we conducted a cross-sectional study among women aged 15 to 49 years, who expressed interest in initiating post abortion intrauterine contraception and were managed with Misoprostol for first trimester incomplete abortions at five health facilities in central Uganda. Healthcare providers received extensive training in post abortion contraceptive counselling and service provision. Data from 650 participants were collected using interviewer administered questionnaires. The primary outcome was uptake of post abortion IUDs, defined as the actual insertion of the post abortion IUDs. Data were collected during a post abortion follow up visit. The determinants of post abortion IUD uptake were assessed using the modified poisson regression. Results: The proportion of women who took up IUDs after medical management of first trimester abortion, was 370/650 (56.9%). Among the other available contraceptive choices, 121(18.6%) women opted for injectable Depo-Provera (DMPA), 116(17.9%) women opted for implants, 35(5.4%) women opted for oral contraceptive pills, five (0.8%) of the women opted for condoms, and three (0.5%) women for periodic abstinence. The mean age of the participants was (27.3 ± SD 1.8) years. A high proportion of the women in the study were; Catholics (32.3%), unemployed (52.6%), cohabiting with their partners (84.0%) and had given birth to 2-3 children (38.5%). A high proportion (56%) of IUD users, opted for the copper IUDs. The post abortion IUD uptake was independently associated with religion- being a Pentecostal (Adjusted PR=2.49, CI= (1.19-5.23), p-value=0.016), monthly earning > one million Ugx (270 USD) (Adjusted PR=1.88, CI= (1.44-2.46), p-value<0.001), and staying <5 kilometres from the health facility (Adjusted PR=1.34, CI= (1.04-1.72), p-value=0.023). Women who were not cohabiting with their partners, were less likely to choose IUDs (Adjusted PR=0.59, CI= (0.44-0.79), p-value=0.001). Conclusion: The uptake of IUDs among post abortion women was nearly 60% emphasizing the potential impacts of integrated contraceptive services in Post abortion care. The impact of comprehensive and updated training on post abortion contraceptive counselling is vital on the uptake of IUDs. Regardless of sociodemographic status, women seeking post abortion care in Uganda should be provided with high-quality integrated services by trained providers offering a range of contraceptive methods. Such efforts may not only prevent unintended pregnancies but also improve health equity across t
{"title":"Uptake of Intrauterine Contraception after Medical Management of First Trimester Incomplete Abortion: A Cross-sectional study in central Uganda","authors":"Herbert Kayiga, Emelie Looft-Trägårdh, Amanda Cleeve, Othman Kakaire, Nazarius Mbona Tumwesigye, Musa Sekikubo, Joseph Rujumba, Kristina Gemzell-Danielsson, Josaphat Byamugisha","doi":"10.1101/2024.09.11.24313496","DOIUrl":"https://doi.org/10.1101/2024.09.11.24313496","url":null,"abstract":"Background: Although intrauterine devices (IUDs) are readily available in Uganda, their utilization remains low, including within post abortion care. The level and factors associated with uptake of post abortion IUDs are not well documented. We set out to determine the uptake and factors associated with uptake of post abortion IUDs after medical management of first trimester incomplete abortions in central Uganda.\u0000Methods: Between February 2023 and September 2023, we conducted a cross-sectional study among women aged 15 to 49 years, who expressed interest in initiating post abortion intrauterine contraception and were managed with Misoprostol for first trimester incomplete abortions at five health facilities in central Uganda. Healthcare providers received extensive training in post abortion contraceptive counselling and service provision. Data from 650 participants were collected using interviewer administered questionnaires. The primary outcome was uptake of post abortion IUDs, defined as the actual insertion of the post abortion IUDs. Data were collected during a post abortion follow up visit. The determinants of post abortion IUD uptake were assessed using the modified poisson regression.\u0000Results: The proportion of women who took up IUDs after medical management of first trimester abortion, was 370/650 (56.9%). Among the other available contraceptive choices, 121(18.6%) women opted for injectable Depo-Provera (DMPA), 116(17.9%) women opted for implants, 35(5.4%) women opted for oral contraceptive pills, five (0.8%) of the women opted for condoms, and three (0.5%) women for periodic abstinence. The mean age of the participants was (27.3 ± SD 1.8) years. A high proportion of the women in the study were; Catholics (32.3%), unemployed (52.6%), cohabiting with their partners (84.0%) and had given birth to 2-3 children (38.5%). A high proportion (56%) of IUD users, opted for the copper IUDs. The post abortion IUD uptake was independently associated with religion- being a Pentecostal (Adjusted PR=2.49, CI= (1.19-5.23), p-value=0.016), monthly earning > one million Ugx (270 USD) (Adjusted PR=1.88, CI= (1.44-2.46), p-value<0.001), and staying <5 kilometres from the health facility (Adjusted PR=1.34, CI= (1.04-1.72), p-value=0.023). Women who were not cohabiting with their partners, were less likely to choose IUDs (Adjusted PR=0.59, CI= (0.44-0.79), p-value=0.001).\u0000Conclusion: The uptake of IUDs among post abortion women was nearly 60% emphasizing the potential impacts of integrated contraceptive services in Post abortion care. The impact of comprehensive and updated training on post abortion contraceptive counselling is vital on the uptake of IUDs. Regardless of sociodemographic status, women seeking post abortion care in Uganda should be provided with high-quality integrated services by trained providers offering a range of contraceptive methods. Such efforts may not only prevent unintended pregnancies but also improve health equity across t","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"73 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142224341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-10DOI: 10.1101/2024.09.09.24313335
Cathy Daichang, Sidney Chu, Helen Nguyen, Adaora Madubuko
Background: This retrospective study examined maternal risk factors and newborn outcomes for unplanned out-of-hospital births (UOHB) brought to an inner-city hospital (Newark, NJ, USA). Unplanned out-of-hospital births have been associated with increased maternal and neonatal complications. Race/ethnicity, low household income and poverty showed significant impact on infant mortality in Newark; investigating factors that influence unplanned out-of-hospital births at an inner-city hospital provides insight into clinical outcomes for at-risk mothers and their children. Methods: 66 unplanned out-of-hospital live births from January 2017 to December 2022 were compared with 72 randomly selected in-hospital live births, controlling for birth weight greater than 500g. Newborns with chromosomal abnormalities, stillbirths, non-singleton births, and congenital anomalies in neonates were excluded from analyses. Standard statistical tests (t-test, chi-square test of independence with Yates correction, and Fishers exact test) were applied in comparing in-hospital birth groups with the unplanned out-of-hospital births group. Results: Unplanned out-of-hospital newborns were more likely to be affected by low birth weight (OR=5.90, 95%CI [1.87, 18.6]), be born preterm (OR=4.84, 95CI% [1.67, 14.1]), and have a significantly lower average gestational age compared to the in-hospital group (p=4.13x10^-3). Hypoglycemia (OR=38.0, 95%CI [4.95, 291]), hypothermia (OR=35.5, 95% CI [4.62, 272]), and bradycardia (OR=15.58, 95% CI [0.86, 282]) were significantly associated with unplanned out-of-hospital births. Developmental delay, APGAR scores, neonatal mortality, and other neonatal complications were not significantly associated with birth location. Mothers of Black/African-American race were significantly more likely to have out-of-hospital births (OR=4.29, 95%CI [2.10, 8.74]). Mothers with unplanned out-of-hospital births were almost eight times more likely to have any substance-use-related ICD codes recorded in maternal charts (OR=7.98, 95%CI [2.22, 28.7]). Mothers with unplanned out-of-hospital births were more likely to receive less than appropriate prenatal care (OR=0.09, 95%CI [0.03, 0.26]) and no prenatal care at all (OR=5.44, 95%CI [1.71, 17.3]). Parity, maternal age at delivery, marital status, insurance, education, use of interpreting services, and employment status of the mother were not significantly associated with birth location. Conclusions: This study revealed multiple significant interconnected associations to UOHB that include insufficient prenatal care, substance use disorder, and demographic variables such as race/ethnicity. UOHB were significantly associated with preterm births, low birth weight, hypoglycemia, hypothermia and bradycardia. These findings emphasize the need for targeted interventions for at-risk populations to decrease the risk of preventable neonatal complications.
{"title":"Impact and factors affecting unplanned out-of-hospital birth on newborns at University Hospital compared to in-hospital born newborns","authors":"Cathy Daichang, Sidney Chu, Helen Nguyen, Adaora Madubuko","doi":"10.1101/2024.09.09.24313335","DOIUrl":"https://doi.org/10.1101/2024.09.09.24313335","url":null,"abstract":"Background: This retrospective study examined maternal risk factors and newborn outcomes for unplanned out-of-hospital births (UOHB) brought to an inner-city hospital (Newark, NJ, USA). Unplanned out-of-hospital births have been associated with increased maternal and neonatal complications. Race/ethnicity, low household income and poverty showed significant impact on infant mortality in Newark; investigating factors that influence unplanned out-of-hospital births at an inner-city hospital provides insight into clinical outcomes for at-risk mothers and their children. Methods: 66 unplanned out-of-hospital live births from January 2017 to December 2022 were compared with 72 randomly selected in-hospital live births, controlling for birth weight greater than 500g. Newborns with chromosomal abnormalities, stillbirths, non-singleton births, and congenital anomalies in neonates were excluded from analyses. Standard statistical tests (t-test, chi-square test of independence with Yates correction, and Fishers exact test) were applied in comparing in-hospital birth groups with the unplanned out-of-hospital births group. Results:\u0000Unplanned out-of-hospital newborns were more likely to be affected by low birth weight (OR=5.90, 95%CI [1.87, 18.6]), be born preterm (OR=4.84, 95CI% [1.67, 14.1]), and have a significantly lower average gestational age compared to the in-hospital group (p=4.13x10^-3). Hypoglycemia (OR=38.0, 95%CI [4.95, 291]), hypothermia (OR=35.5, 95% CI [4.62, 272]), and bradycardia (OR=15.58, 95% CI [0.86, 282]) were significantly associated with unplanned out-of-hospital births. Developmental delay, APGAR scores, neonatal mortality, and other neonatal complications were not significantly associated with birth location. Mothers of Black/African-American race were significantly more likely to have out-of-hospital births (OR=4.29, 95%CI [2.10, 8.74]). Mothers with unplanned out-of-hospital births were almost eight times more likely to have any substance-use-related ICD codes recorded in maternal charts (OR=7.98, 95%CI [2.22, 28.7]). Mothers with unplanned out-of-hospital births were more likely to receive less than appropriate prenatal care (OR=0.09, 95%CI [0.03, 0.26]) and no prenatal care at all (OR=5.44, 95%CI [1.71, 17.3]). Parity, maternal age at delivery, marital status, insurance, education, use of interpreting services, and employment status of the mother were not significantly associated with birth location. Conclusions:\u0000This study revealed multiple significant interconnected associations to UOHB that include insufficient prenatal care, substance use disorder, and demographic variables such as race/ethnicity. UOHB were significantly associated with preterm births, low birth weight, hypoglycemia, hypothermia and bradycardia. These findings emphasize the need for targeted interventions for at-risk populations to decrease the risk of preventable neonatal complications.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142224354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-05DOI: 10.1101/2024.09.04.24313073
Mugyenyi R Godfrey, Tumuhimbise Wilson, Atukunda C Esther, Tibaijuka Leevan, Ngonzi Joseph, Kayondo Musa, Kanyesigye Micheal, Musimenta Angella, Yarine T Fajardo, Byamugisha K Josaphat
Background Obstructed labour, a sequel of prolonged labour, remains a significant contributor to maternal and perinatal deaths in low- and middle-income countries.
背景 在中低收入国家，产程过长导致的难产仍然是孕产妇和围产期死亡的一个重要原因。
{"title":"Effectiveness of the modified WHO labour care guide to detect prolonged and obstructed labour among women admitted at publicly funded facilities in rural Mbarara district, Southwestern Uganda: an ambispective cohort study","authors":"Mugyenyi R Godfrey, Tumuhimbise Wilson, Atukunda C Esther, Tibaijuka Leevan, Ngonzi Joseph, Kayondo Musa, Kanyesigye Micheal, Musimenta Angella, Yarine T Fajardo, Byamugisha K Josaphat","doi":"10.1101/2024.09.04.24313073","DOIUrl":"https://doi.org/10.1101/2024.09.04.24313073","url":null,"abstract":"<strong>Background</strong> Obstructed labour, a sequel of prolonged labour, remains a significant contributor to maternal and perinatal deaths in low- and middle-income countries.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142185480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-04DOI: 10.1101/2024.09.03.24312808
Shujing Yang, Huanyao Liu, Jieshi Hu, Bingjun Chen, Wanlu An, Xuwen Song, Yi Yang, Fang He
Pre-eclampsia (PE) is a serious pregnancy disorder linked to genetic factors, particularly the ACVR2A gene, which encodes a receptor involved in the activin signaling pathway and plays a critical role in reproductive processes. Transcriptomic data analysis and experimental verification confirmed a downregulation of ACVR2A expression in placental tissues from PE patients. In this study, CRISPR/Cas9 technology was employed to investigate the effect of ACVR2A gene deletion on trophoblast cells using the HTR8/SVneo and JAR cell lines.. Deletion of ACVR2A inhibits trophoblastic migration, proliferation, and invasion, underscoring its pivotal role in cellular function. RNA-seq data analysis unveiled an intricate regulatory network influenced by ACVR2A gene knockout, especially in the TCF7/c-JUN pathway. By employing RT-PCR and immunohistochemical analysis, a potential association between ACVR2A and the TCF7/c-JUN pathway was hypothesized and confirmed. The complexity of PE onset and the significance of genetic factors were emphasized, particularly the role of the ACVR2A gene identified in GWAS. This study established a robust foundation for delving deeper into the intricate mechanisms of PE, paving the way for focused early intervention, personalized treatment, and enhanced obstetric healthcare.
子痫前期（PE）是一种与遗传因素有关的严重妊娠疾病，尤其是 ACVR2A 基因，该基因编码的受体参与活化素信号通路，在生殖过程中发挥关键作用。转录组数据分析和实验验证证实，PE 患者胎盘组织中 ACVR2A 表达下调。本研究采用CRISPR/Cas9技术，利用HTR8/SVneo和JAR细胞系研究了ACVR2A基因缺失对滋养层细胞的影响。ACVR2A基因缺失会抑制滋养层细胞的迁移、增殖和侵袭，突显了它在细胞功能中的关键作用。RNA-seq数据分析揭示了一个受ACVR2A基因敲除影响的复杂调控网络，尤其是在TCF7/c-JUN通路中。通过 RT-PCR 和免疫组化分析，假设并证实了 ACVR2A 与 TCF7/c-JUN 通路之间的潜在关联。研究强调了 PE 发病的复杂性和遗传因素的重要性，尤其是在 GWAS 中发现的 ACVR2A 基因的作用。这项研究为深入研究 PE 的复杂机制奠定了坚实的基础，为有针对性的早期干预、个性化治疗和加强产科保健铺平了道路。
{"title":"ACVR2A Facilitates Trophoblast Cell Invasion through TCF7/c-JUN Pathway in Pre-eclampsia Progression","authors":"Shujing Yang, Huanyao Liu, Jieshi Hu, Bingjun Chen, Wanlu An, Xuwen Song, Yi Yang, Fang He","doi":"10.1101/2024.09.03.24312808","DOIUrl":"https://doi.org/10.1101/2024.09.03.24312808","url":null,"abstract":"Pre-eclampsia (PE) is a serious pregnancy disorder linked to genetic factors, particularly the ACVR2A gene, which encodes a receptor involved in the activin signaling pathway and plays a critical role in reproductive processes. Transcriptomic data analysis and experimental verification confirmed a downregulation of ACVR2A expression in placental tissues from PE patients. In this study, CRISPR/Cas9 technology was employed to investigate the effect of ACVR2A gene deletion on trophoblast cells using the HTR8/SVneo and JAR cell lines.. Deletion of ACVR2A inhibits trophoblastic migration, proliferation, and invasion, underscoring its pivotal role in cellular function. RNA-seq data analysis unveiled an intricate regulatory network influenced by ACVR2A gene knockout, especially in the TCF7/c-JUN pathway. By employing RT-PCR and immunohistochemical analysis, a potential association between ACVR2A and the TCF7/c-JUN pathway was hypothesized and confirmed. The complexity of PE onset and the significance of genetic factors were emphasized, particularly the role of the ACVR2A gene identified in GWAS. This study established a robust foundation for delving deeper into the intricate mechanisms of PE, paving the way for focused early intervention, personalized treatment, and enhanced obstetric healthcare.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"53 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142185479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Back ground Pelvic organ prolapse (POP) is a common condition that can significantly impact a woman’s quality of life. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment for prolapse, but evidence on its effectiveness from low-resource settings is limited.
{"title":"Effect of Midwife-Led Pelvic Floor Muscle Training on Prolapse Symptoms and Quality of Life in Women with Pelvic Organ Prolapse in Ethiopia: A Cluster-Randomized Controlled Trial","authors":"Melese Siyoum, Rahel Nardos, Biniyam Sirak, Theresa Spitznagle, Wondwosen Teklesilasie, Ayalew Astatkie","doi":"10.1101/2024.08.30.24312827","DOIUrl":"https://doi.org/10.1101/2024.08.30.24312827","url":null,"abstract":"<strong>Back ground</strong> Pelvic organ prolapse (POP) is a common condition that can significantly impact a woman’s quality of life. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment for prolapse, but evidence on its effectiveness from low-resource settings is limited.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142185478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-28DOI: 10.1101/2024.08.27.24312651
Chemtai Mungo, Konyin Adewumi, Mercy Rop, Antony Owaya, Everlyn Adoyo, Aparna Ghosh Kachoria, Jennifer Tang, Lisa Rahangdale
BACKGROUND: Innovative strategies are essential to meet the World Health Organizations 90/70/90 cervical cancer elimination targets, aiming for 90% access to precancer treatment globally by 2030. In low-and middle-income countries (LMICs) where most cervical cancer cases occur, access to precancer treatment is severely limited. Scalable solutions like self-administered topical therapies can help close this gap. In a recent Phase I trial (ClinicalTrials.gov NCT05362955), we demonstrated safety and adherence to self-administered intravaginal 5% 5-Fluorouracil (5FU) cream as an adjuvant therapy for cervical precancer among women living with HIV (WLWH) in rural Kenya. To understand womens experiences with self-administered 5FU, we evaluated the acceptability of this intervention among trial participants. METHODS: All 12 participants from the Phase I trial completed a structured questionnaire and in-depth semi-structured interviews in their preferred language, focusing on their experiences with 5FU self-administration, challenges faced, and overall acceptability of the intervention, including whether they would use it again or recommend it to someone who needed it. Quantitative data were analyzed using descriptive statistics. In the qualitative study, acceptability was defined as ″the perception that a given treatment is agreeable, palatable, or satisfactory.″ A thematic analysis was conducted using five dimensions of acceptability: content, complexity, comfort, delivery, and credibility. RESULTS: The mean age was 43.9 years (SD 4.4), and 7 (58%) had primary education or less. While some participants reported feelings of uncertainty when they started using 5FU, at the end of the study, all twelve participants strongly agreed that the cream was safe and were confident they used it correctly. Most participants (91.7%) experienced no discomfort with the vaginal applicator, and most reported using tampons overnight after 5FU use, as recommended. Qualitative findings revealed that favorable perceptions of self-administered 5FU were driven by its ease of use, the discrete nature of the treatment, and the comfort of home application. The main challenges included correctly measuring the study drug, finding a private place at home to self-administer, and the need to use condoms during treatment. Compared to their previous ablation or excision treatments, participants found 5FU to be less painful, and all would prefer a self-administered treatment instead of a procedure if it were an option. CONCLUSION: Self-administered intravaginal 5FU as an adjuvant treatment for cervical precancer among women living with HIV in Kenya was highly acceptable. Randomized studies of 5FU and other topical therapies in LMICs are needed to evaluate their use in closing the current precancer treatment gaps in these settings.
{"title":"Womens experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya","authors":"Chemtai Mungo, Konyin Adewumi, Mercy Rop, Antony Owaya, Everlyn Adoyo, Aparna Ghosh Kachoria, Jennifer Tang, Lisa Rahangdale","doi":"10.1101/2024.08.27.24312651","DOIUrl":"https://doi.org/10.1101/2024.08.27.24312651","url":null,"abstract":"BACKGROUND: Innovative strategies are essential to meet the World Health Organizations 90/70/90 cervical cancer elimination targets, aiming for 90% access to precancer treatment globally by 2030. In low-and middle-income countries (LMICs) where most cervical cancer cases occur, access to precancer treatment is severely limited. Scalable solutions like self-administered topical therapies can help close this gap. In a recent Phase I trial (ClinicalTrials.gov NCT05362955), we demonstrated safety and adherence to self-administered intravaginal 5% 5-Fluorouracil (5FU) cream as an adjuvant therapy for cervical precancer among women living with HIV (WLWH) in rural Kenya. To understand womens experiences with self-administered 5FU, we evaluated the acceptability of this intervention among trial participants.\u0000METHODS: All 12 participants from the Phase I trial completed a structured questionnaire and in-depth semi-structured interviews in their preferred language, focusing on their experiences with 5FU self-administration, challenges faced, and overall acceptability of the intervention, including whether they would use it again or recommend it to someone who needed it. Quantitative data were analyzed using descriptive statistics. In the qualitative study, acceptability was defined as ″the perception that a given treatment is agreeable, palatable, or satisfactory.″ A thematic analysis was conducted using five dimensions of acceptability: content, complexity, comfort, delivery, and credibility.\u0000RESULTS: The mean age was 43.9 years (SD 4.4), and 7 (58%) had primary education or less. While some participants reported feelings of uncertainty when they started using 5FU, at the end of the study, all twelve participants strongly agreed that the cream was safe and were confident they used it correctly. Most participants (91.7%) experienced no discomfort with the vaginal applicator, and most reported using tampons overnight after 5FU use, as recommended. Qualitative findings revealed that favorable perceptions of self-administered 5FU were driven by its ease of use, the discrete nature of the treatment, and the comfort of home application. The main challenges included correctly measuring the study drug, finding a private place at home to self-administer, and the need to use condoms during treatment. Compared to their previous ablation or excision treatments, participants found 5FU to be less painful, and all would prefer a self-administered treatment instead of a procedure if it were an option. CONCLUSION: Self-administered intravaginal 5FU as an adjuvant treatment for cervical precancer among women living with HIV in Kenya was highly acceptable. Randomized studies of 5FU and other topical therapies in LMICs are needed to evaluate their use in closing the current precancer treatment gaps in these settings.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142224358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-26DOI: 10.1101/2024.08.25.24312541
Connor L Allen, Eva Naznin, Timothy JR Panneflek, Tina Lavin, Enamul Hoque
Abstract Background: Early-onset Group B Streptococcus (EOGBS) infection is one of the most prevalent neonatal infections globally, contributing to significant infant morbidity and mortality by inducing life threatening sequelae such as sepsis, meningitis and pneumonia. EOGBS infection occurs within 7 days of birth following vertical transmission of the bacteria from a colonised pregnant woman to her infant. Current strategies aimed at preventing EOGBS focus on the administration of intrapartum antibiotic prophylaxis (IAP). There is no universally agreed upon strategy for how to best identify which pregnant women should receive IAP. Currently there are four main strategies employed by health systems: 1) risk -based approach where women are assessed for risk factors for newborn EOGBS and IAP is administered to women who have at least one risk factor; 2) universal screening where all women are screened antenatally for GBS colonisation and are given IAP upon testing positive; 3) a combination of a risk-based approach and universal screening, and 4) no strategy for screening strategy with IAP administered on a case-by-case basis. Despite evidence suggesting that a universal screening strategy may be most efficacious in reducing EOGBS incidence, each screening strategy carries with it different costs and economic burdens, depending on the setting. Therefore, recommendations as to which screening strategy is most suitable must be made in the context of both sound clinical and economic evidence. Methods: This review synthesised and compared economic evaluations of maternal GBS screening strategies. A systematic search for evidence relating to GBS screening strategies was performed in the databases MEDLINE, Embase and Web of Science. Studies were included if they reported on a strategy to assess women for IAP administration and the outcomes of interest. This paper presents the findings of economic evaluations identified by this search. The economic findings of each study were compared and synthesised narratively due to significant heterogeneity among included studies preventing meta-analysis. Results: A total of 18 studies were identified for inclusion in this review. These studies, all from high-income countries, cumulatively made 58 comparisons of GBS screening strategies and cost-effectiveness analyses. Studies either compared any type of screening to no screening strategy (Universal screening vs no screening; risk-based approach vs no screening; combined screening vs no screening) or compared different screening strategies to each other. The implementation of any screening strategy was found to be cost-effective compared to none at all depending on the setting (one instance using universal screening, two using risk-factor approach and four using a combined strategy). On multiple occasions, cost-effectiveness varied significantly depending on the prevalence of maternal GBS colonisation. Discussion: This review demonstrated that in several instances th
{"title":"The Cost-Effectiveness of Group B Streptococcus Screening Strategies in Pregnant Women for the Prevention of Newborn Early-onset Group B Streptococcus : A Systematic Review","authors":"Connor L Allen, Eva Naznin, Timothy JR Panneflek, Tina Lavin, Enamul Hoque","doi":"10.1101/2024.08.25.24312541","DOIUrl":"https://doi.org/10.1101/2024.08.25.24312541","url":null,"abstract":"Abstract\u0000Background: Early-onset Group B Streptococcus (EOGBS) infection is one of the most prevalent neonatal infections globally, contributing to significant infant morbidity and mortality by inducing life threatening sequelae such as sepsis, meningitis and pneumonia. EOGBS infection occurs within 7 days of birth following vertical transmission of the bacteria from a colonised pregnant woman to her infant. Current strategies aimed at preventing EOGBS focus on the administration of intrapartum antibiotic prophylaxis (IAP). There is no universally agreed upon strategy for how to best identify which pregnant women should receive IAP. Currently there are four main strategies employed by health systems: 1) risk -based approach where women are assessed for risk factors for newborn EOGBS and IAP is administered to women who have at least one risk factor; 2) universal screening where all women are screened antenatally for GBS colonisation and are given IAP upon testing positive; 3) a combination of a risk-based approach and universal screening, and 4) no strategy for screening strategy with IAP administered on a case-by-case basis. Despite evidence suggesting that a universal screening strategy may be most efficacious in reducing EOGBS incidence, each screening strategy carries with it different costs and economic burdens, depending on the setting. Therefore, recommendations as to which screening strategy is most suitable must be made in the context of both sound clinical and economic evidence. Methods: This review synthesised and compared economic evaluations of maternal GBS screening strategies. A systematic search for evidence relating to GBS screening strategies was performed in the databases MEDLINE, Embase and Web of Science. Studies were included if they reported on a strategy to assess women for IAP administration and the outcomes of interest. This paper presents the findings of economic evaluations identified by this search. The economic findings of each study were compared and synthesised narratively due to significant heterogeneity among included studies preventing meta-analysis. Results: A total of 18 studies were identified for inclusion in this review. These studies, all from high-income countries, cumulatively made 58 comparisons of GBS screening strategies and cost-effectiveness analyses. Studies either compared any type of screening to no screening strategy (Universal screening vs no screening; risk-based approach vs no screening; combined screening vs no screening) or compared different screening strategies to each other. The implementation of any screening strategy was found to be cost-effective compared to none at all depending on the setting (one instance using universal screening, two using risk-factor approach and four using a combined strategy). On multiple occasions, cost-effectiveness varied significantly depending on the prevalence of maternal GBS colonisation. Discussion: This review demonstrated that in several instances th","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142224361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-22DOI: 10.1101/2024.08.21.24312387
Joshua Stephen Kileo, Shubi Matovelo, Gabriel Kitinusa
Severe pre-eclampsia is managed by using Magnesium sulphate to prevent its progress into eclampsia with a success rate of more than 50%. This study aimed at establishing reliable data pertaining factors influencing pharmacologic serum concentration of Magnesium and their correlation to obstetric outcomes. This study was carried out at Iringa regional referral hospital, spanning six months from November 2023 to April 2024. A convenient sampling technique was used to recruit 121 pre-eclamptic patients. Recruited women were tested serum Magnesium at admission, 4 and 12 hours post initial administration of MgSO4. IBM SPSS version 29 was used for analysis where, Continuous variables were analyzed by using median and interquartile range while categorical variables were analyzed using frequency and percentages. The associations between variables were determined using chi-square tests, univariate, and multivariate binary regression models. A p value<0.05 was considered statistically significant. Results: The median age of participants were (29±10 IQR), the median serum Mg at admission was (0.8±0.29 IQR) Mmol/L majority with low 53(43.8%) levels. Proportion of subtherapeutic serum Mg was 38.8% with median of (1.9±1.02 IQR) Mmol/L. Multivariate regression showed that; low serum Mg at admission [p<0.001, OR= 9.17, 95% CI (3.07- 27.37)], Creatinine level [p = 0.012, OR= 4.49, 95% CI (1.38- 14.6)], Overweight [p= 0.002, OR= 5.52, 95% CI (1.83- 16.68)] and proteinuria +++[p-value = 0.004, OR= 7.13, 95% CI (1.84- 26.86)] were significantly associated with subtherapeutic level. After adjusting with other factors, it was found that subtherapeutic level [p<0.001, OR=25.44(5.73-112.90)], elevated creatinine [p=0.040, OR=3.59(1.66-12.15)], Reduced urine output [p=0.001, OR=6.69(2.15-20.90)] were significant predictors of adverse maternal outcomes. Conclusion: Subtherapeutic serum Magnesium which significantly predict adverse obstetric outcomes, is influenced by factors which can be monitored and be useful in effective management of severe pre-eclampsia. This can help in administering tailored dose of MgSO4 for better outcomes.
{"title":"FACTORS ASSOCIATED WITH PHARMACOLOGIC SERUM CONCENTRATION OF MAGNESIUM AND CORRESPONDING OBSTETRIC OUTCOMES AMONG WOMEN WITH SEVERE PRE-ECLAMPSIA AT IRINGA REGIONAL REFERRAL HOSPITAL","authors":"Joshua Stephen Kileo, Shubi Matovelo, Gabriel Kitinusa","doi":"10.1101/2024.08.21.24312387","DOIUrl":"https://doi.org/10.1101/2024.08.21.24312387","url":null,"abstract":"Severe pre-eclampsia is managed by using Magnesium sulphate to prevent its progress into eclampsia with a success rate of more than 50%. This study aimed at establishing reliable data pertaining factors influencing pharmacologic serum concentration of Magnesium and their correlation to obstetric outcomes.\u0000This study was carried out at Iringa regional referral hospital, spanning six months from November 2023 to April 2024. A convenient sampling technique was used to recruit 121 pre-eclamptic patients. Recruited women were tested serum Magnesium at admission, 4 and 12 hours post initial administration of MgSO4. IBM SPSS version 29 was used for analysis where, Continuous variables were analyzed by using median and interquartile range while categorical variables were analyzed using frequency and percentages. The associations between variables were determined using chi-square tests, univariate, and multivariate binary regression models. A p value<0.05 was considered statistically significant. Results: The median age of participants were (29±10 IQR), the median serum Mg at admission was (0.8±0.29 IQR) Mmol/L majority with low 53(43.8%) levels. Proportion of subtherapeutic serum Mg was 38.8% with median of (1.9±1.02 IQR) Mmol/L. Multivariate regression showed that; low serum Mg at admission [p<0.001, OR= 9.17, 95% CI (3.07- 27.37)], Creatinine level [p = 0.012, OR= 4.49, 95% CI (1.38- 14.6)], Overweight [p= 0.002, OR= 5.52, 95% CI (1.83- 16.68)] and proteinuria +++[p-value = 0.004, OR= 7.13, 95% CI (1.84- 26.86)] were significantly associated with subtherapeutic level. After adjusting with other factors, it was found that subtherapeutic level [p<0.001, OR=25.44(5.73-112.90)], elevated creatinine [p=0.040, OR=3.59(1.66-12.15)], Reduced urine output [p=0.001, OR=6.69(2.15-20.90)] were significant predictors of adverse maternal outcomes. Conclusion: Subtherapeutic serum Magnesium which significantly predict adverse obstetric outcomes, is influenced by factors which can be monitored and be useful in effective management of severe pre-eclampsia. This can help in administering tailored dose of MgSO4 for better outcomes.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142185481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-21DOI: 10.1101/2024.08.20.24312284
Zoe Bradfield, Scott White, Miranda Davies-Tuck, Mary Sharp, Jane Warland, Emily Callander, Lesley Kuliukas, Monique Rose, Amber Pettitt, Kylie Ekin, Dorota Doherty, Jeffrey Keelan
Introduction Around the world, rates of induction of labour (IOL) amongst nulliparous mothers have increased in the last 10 years. In Australia, rates have increased over the last decade by 43%, from 32% to 46%. There is growing concern about the rapid rise in IOL before 41 weeks for nulliparous women without medical complications because of the associated increased rates of caesarean section, reduced satisfaction with birth, and birth trauma. Melatonin potentiates the action of oxytocin and may promote the spontaneous onset of labour; therefore, we will test the hypothesis that exogenous melatonin supplementation in late pregnancy will reduce the rate of labour induction by 30% or more. Methods and analyses This is a double-blind, randomised, placebo-controlled trial in nulliparous pregnant women to reduce IOL rates. We will randomise 530 women to receive either 3 mg oral melatonin or placebo daily from 39+0 weeks gestation until they give birth. The primary endpoint will be IOL rate after 39 weeks. Secondary endpoints will include: interval between administration of trial medication and birth; a range of maternal and neonatal outcomes, including birth outcomes; breastfeeding on discharge, at 10 days and at 2 months; maternal satisfaction; child developmental outcomes at 2 months of age; and cost-effectiveness of melatonin compared with standard care. All data will be analysed by intention to treat.
{"title":"A double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women. The MyTIME study protocol.","authors":"Zoe Bradfield, Scott White, Miranda Davies-Tuck, Mary Sharp, Jane Warland, Emily Callander, Lesley Kuliukas, Monique Rose, Amber Pettitt, Kylie Ekin, Dorota Doherty, Jeffrey Keelan","doi":"10.1101/2024.08.20.24312284","DOIUrl":"https://doi.org/10.1101/2024.08.20.24312284","url":null,"abstract":"Introduction\u0000Around the world, rates of induction of labour (IOL) amongst nulliparous mothers have increased in the last 10 years. In Australia, rates have increased over the last decade by 43%, from 32% to 46%. There is growing concern about the rapid rise in IOL before 41 weeks for nulliparous women without medical complications because of the associated increased rates of caesarean section, reduced satisfaction with birth, and birth trauma. Melatonin potentiates the action of oxytocin and may promote the spontaneous onset of labour; therefore, we will test the hypothesis that exogenous melatonin supplementation in late pregnancy will reduce the rate of labour induction by 30% or more. Methods and analyses\u0000This is a double-blind, randomised, placebo-controlled trial in nulliparous pregnant women to reduce IOL rates. We will randomise 530 women to receive either 3 mg oral melatonin or placebo daily from 39+0 weeks gestation until they give birth. The primary endpoint will be IOL rate after 39 weeks. Secondary endpoints will include: interval between administration of trial medication and birth; a range of maternal and neonatal outcomes, including birth outcomes; breastfeeding on discharge, at 10 days and at 2 months; maternal satisfaction; child developmental outcomes at 2 months of age; and cost-effectiveness of melatonin compared with standard care. All data will be analysed by intention to treat.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"157 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142185483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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