Obstetrics and gynecology最新文献

Objective: To compare patient satisfaction, health care resource utilization, and adverse events among patients receiving a virtual video compared with in-office postoperative visit after urogynecologic surgery. We hypothesized that virtual video visits would be noninferior to in-office visits.

Methods: This was a randomized noninferiority clinical trial of patients undergoing surgery for pelvic organ prolapse and urinary incontinence at a single academic tertiary referral center. Participants were randomized to receive either a virtual video postoperative visit or a standard in-office postoperative visit. The primary outcome was patient satisfaction measured by the validated PSQ-18 (Patient Satisfaction Questionnaire-18) (noninferiority margin 5 points) at the 6-week postoperative visit. Secondary outcomes included PSQ-18 domain scores (noninferiority margin 0.5 points) and composite health care resource utilization and adverse events after the 6-week postoperative visit up to 12 weeks after surgery (noninferiority margin 10%). A sample size of 100 participants (50 per group) would allow 80% power to assess a 5-point noninferiority margin on the total PSQ-18 with an SD of 10 and α=0.05.

Results: From January 2023 to September 2023, 265 patients were screened for eligibility, and 104 were randomized. A total of 100 participants (50 per arm) completed the study and were included in the analysis. The mean±SD age of all participants was 57.0±13.2 years. The mean±SD PSQ-18 total score was 75.18±8.15 in the virtual group and 75.14±8.7 in the in-office group. The mean PSQ-18 total score was 0.04 points higher (ie, greater degree of satisfaction) in the virtual group, with a 95% CI of -2.75 to 2.83, which met the criterion for noninferiority. Between-group differences for all PSQ-18 domain scores likewise met criterion for noninferiority. Composite health care resource utilization was 14.0% lower in the virtual group than in the in-office group (20.0% vs 34.0%, 95% CI, -28.0% to 1.0%). For composite adverse events, the between-group difference was 2.0% (2.0% in virtual group vs 0.0% in in-office group, 95% CI,-3.0% to 8.0%).

Conclusion: Virtual video postoperative visits were noninferior to in-office visits with regard to patient satisfaction, health care resource utilization, and adverse events and can be offered as an alternative to in-office visits for postoperative follow-up after urogynecologic surgery.

Clinical trial registration: ClinicalTrials.gov, NCT05641077.

Objective: To systematically review and meta-analyze alloimmunization among recipients of red blood cells (RBCs) matched for ABO blood type and Rhesus D (ABO+D) antigen compared with those also matched for c, E, and Kell (cEK).

Data sources: Four online databases (Medline, Scopus, EMBASE, ClinicalTrials.gov) were searched from March 28, 2023, to April 1, 2024. The search protocol was peer reviewed and published on PROSPERO (CRD42023411620).

Methods of study selection: Studies reporting alloimmunization as the primary outcome among recipients of RBCs matched for ABO+D or additional cEK matching were included. Patients transfused with unmatched RBCs or a mixture of matching regimens were excluded. Risk of bias was assessed with Cochrane Tool to Assess Risk of Bias in Cohort Studies and Tool for Risk of Bias. Random-effects meta-analysis was used to combine effect estimates.

Tabulation, integration, and results: Ten studies met criteria. Risk of bias was low. Overall, 91,221 patients were transfused, of whom 40,220 (44.1%) received additional cEK-matched RBCs. The overall rate of alloimmunization was 6.2% (95% CI, 2.5-14.9%) for ABO+D-only matching and 1.9% (95% CI, 0.7-5.1%) when cEK was added. Time of follow-up antibody testing ranged from 6 to 18 months after transfusion. Additional cEK match was associated with significantly less alloimmunization compared with standard ABO+D match (odds ratio [OR] 0.37, 95% CI, 0.20-0.69). This association remained when chronically transfused patients were excluded (OR 0.65, 95% CI, 0.54-0.79) and for alloimmunization to c, E, or K antigens only (OR 0.29, 95% CI, 0.18-0.47).

Conclusion: Additional cEK RBC matching protocols were associated with lower odds of recipient alloimmunization. Given severe sequelae of alloimmunization in pregnancy, routine cEK matching for transfusion in people with pregnancy potential younger than age 50 years in the United States merits consideration.

Systematic review registration: PROSPERO, CRD42023411620.

Objective: To examine the association of universal question-based screening for prenatal substance use on racial inequities in prenatal and newborn drug testing.

Methods: We conducted a retrospective cohort study of 32,802 live births of patients receiving prenatal care at an academic medical center in the midwestern United States from 2014 to 2022, before and after implementation of question-based screening in 2018. Primary outcomes included prenatal and newborn drug test orders. Logistic regression models using a generalized estimating equation framework assessed associations with question-based screening and results, birthing parent age, race, ethnicity, marital status, and insurance type. Charts of patients who indicated difficulties stopping substance use were audited for guideline-directed care.

Results: A total of 12,725 of 14,992 pregnant people (85.3%) received question-based screening. Implementation of question-based screening was associated with a decrease in prenatal urine test orders (5.0% [95% CI, 4.6-5.3%] before implementation, 3.1% [95% CI, 2.8-3.4%] after implementation; P <.001), with Black birthing parents having the largest reduction in prenatal urine drug testing (10.3% [95% CI, 9.0-11.7%] before implementation, 4.9% [95% CI, 3.9-5.9%] after implementation). However, rates of newborn drug testing did not change (4.7% [95% CI, 4.4-5.0%] before implementation, 4.5% [95% CI, 4.2-4.8%] after implementation; P =.46), and clinicians continued to order significantly more newborn drug tests for newborns of Black birthing parents compared with other race and ethnicity groups.

Conclusion: Implementation of question-based screening for substance use in pregnancy was associated with decreased prenatal urine drug testing but no change in overall newborn drug testing or racial inequities in newborn drug testing for Black birthing people. Further policy efforts are warranted to improve substance use treatment and to eliminate racial inequities in punitive policies such as newborn drug testing and subsequent child protective services reporting.

Previous models for prediction of vaginal birth after cesarean (VBAC) relied on race and ethnicity, raising concern for bias. In response, the Maternal-Fetal Medicine Units Network (MFMU) created a new prediction model without race and ethnicity for individuals with one prior cesarean delivery. We performed a secondary analysis of the MFMU Cesarean Registry database to evaluate whether the MFMU VBAC prediction model without race and ethnicity could accurately predict VBAC for individuals with two prior cesarean deliveries. Overall, 353 individuals were included and 252 (71%) had VBAC. An area under the curve for the receiver operating curve of 0.74 (95% CI, 0.69-0.80) was reported for the predicted probabilities for VBAC, indicating that the model can be used for prediction of VBAC in this population.

We identified U.S. reports of postmenopausal bleeding in the VAERS (Vaccine Adverse Event Reporting System) between December 13, 2020, and December 13, 2021. Among 711,224 VAERS reports after coronavirus disease 2019 (COVID-19) vaccination, during our study period, we identified 554 presumptive postmenopausal bleeding reports; 434 were further classified as verified based on data abstracted from reports and medical records, when available. In the United States, by December 14, 2021, 58.8 million women aged 50 years or older had received at least one dose of a COVID-19 vaccine, corresponding to approximately seven verified VAERS postmenopausal bleeding reports per 1 million women aged 50 years or older who received a COVID-19 vaccine. Reports of postmenopausal bleeding after COVID-19 vaccination in VAERS were rare, and causes of postmenopausal bleeding based on medical record review were consistent with known causes of postmenopausal bleeding.

Objective: Despite the well-recognized association between pre-existing diabetes mellitus and stillbirth or perinatal mortality, there remain knowledge gaps about the strength of association across different populations. The primary objective of this systematic review and meta-analysis was to quantify the association between pre-existing diabetes and stillbirth or perinatal mortality, and secondarily, to identify risk factors predictive of stillbirth or perinatal mortality among those with pre-existing diabetes.

Data sources: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials from inception to April 2022.

Methods of study selection: Cohort studies and randomized controlled trials in English or French that examined the association between pre-existing diabetes and stillbirth or perinatal mortality (as defined by the original authors) or identified risk factors for stillbirth and perinatal mortality in individuals with pre-existing diabetes were included. Data extraction was performed independently and in duplicate with the use of prespecified inclusion and exclusion criteria. Assessment for heterogeneity and risk of bias was performed. Meta-analyses were completed with a random-effects model.

Tabulation, integration, and results: From 7,777 citations, 91 studies met the inclusion criteria. Pre-existing diabetes was associated with higher odds of stillbirth (37 studies; pooled odds ratio [OR] 3.74, 95% CI, 3.17-4.41, I2=82.5%) and perinatal mortality (14 studies; pooled OR 3.22, 95% CI, 2.54-4.07, I2=82.7%). Individuals with type 1 diabetes had lower odds of stillbirth (pooled OR 0.81, 95% CI, 0.68-0.95, I2=0%) and perinatal mortality (pooled OR 0.73, 95% CI, 0.61-0.87, I2=0%) compared with those with type 2 diabetes. Prenatal care and prepregnancy diabetes care were significantly associated with lower odds of stillbirth (OR 0.26, 95% CI, 0.11-0.62, I2=87.0%) and perinatal mortality (OR 0.41, 95% CI, 0.29-0.59, I2=0%).

Conclusion: Pre-existing diabetes confers a more than threefold increased odds of both stillbirth and perinatal mortality. Maternal type 2 diabetes was associated with a higher risk of stillbirth and perinatal mortality compared with maternal type 1 diabetes.

Systematic review registration: PROSPERO, CRD42022303112.

Objective: To assess the efficacy of topical sildenafil cream, 3.6% among healthy premenopausal women with female sexual arousal disorder.

Methods: We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream. Coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ28 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale-Desire, Arousal, Orgasm).

Results: Two hundred women with female sexual arousal disorder were randomized to sildenafil cream (n=101) or placebo cream (n=99). A total of 174 participants completed the study (sildenafil 90, placebo 84). Among the intention-to-treat (ITT) population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, although the sildenafil cream group demonstrated greater improvement in the SFQ28 Arousal Sensation domain scores, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. An exploratory post hoc subset of the ITT population with an enrollment diagnosis of female sexual arousal disorder with or without concomitant decreased desire randomized to sildenafil cream reported significant increases in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) compared with placebo cream (least squares mean 0.08 [SE 0.71], P =.04). This subset achieved a larger mean improvement in the SFQ28 Desire and Orgasm domain scores. This subset population also had significantly reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by FSDS-DAO questions 3, 5, and 10 (all P ≤.04).

Conclusion: Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress.

Clinical trial registration: ClinicalTrials.gov , NCT04948151.

This study aimed to characterize pregnant individuals' use of cannabidiol (CBD). Data are from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of individuals aged 16-65 years in the United States and Canada (N=66,457 women, including 1,096 pregnant women). The primary analysis compared pregnant and nonpregnant women's CBD-only product use patterns and reasons for use. The prevalence of CBD-only use in pregnant women was 20.4% compared with 11.3% among nonpregnant women, P <.001. Reasons for CBD use among pregnant women included anxiety (58.4%), depression (40.3%), posttraumatic stress disorder (32.1%); pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%). Thus, CBD-only product use was prevalent in this large sample, with one in five pregnant women reporting use. Characterization of prenatal CBD use is an important first step to exploring potential risks to exposed offspring.

Objective: To systematically review the evidence for the effectiveness and safety of magnesium sulfate as a fetal neuroprotective agent when given to individuals at risk of preterm birth.

Data sources: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov , the World Health Organization International Clinical Trials Registry Platform (through March 17, 2023), and reference lists of relevant studies.

Methods of study selection: Randomized controlled trials (RCTs) assessing magnesium sulfate for fetal neuroprotection in pregnant participants at risk of imminent preterm birth were eligible. Two authors assessed RCTs for inclusion, extracted data, and evaluated risk of bias, trustworthiness, and evidence certainty (GRADE [Grading of Recommendations Assessment, Development and Evaluation]).

Tabulation, integration, and results: We included six RCTs (5,917 pregnant participants and 6,759 fetuses at less than 34 weeks of gestation at randomization). They were conducted in high-income countries (two in the United States, two across Australia and New Zealand, and one each in Denmark and France) and commenced between 1995 and 2018. Primary outcomes: up to 2 years of corrected age, magnesium sulfate compared with placebo reduced the risk of cerebral palsy (risk ratio [RR] 0.71, 95% CI, 0.57-0.89; six RCTs, 6,107 children) and death or cerebral palsy (RR 0.87, 95% CI, 0.77-0.98; six RCTs, 6,481 children) (high-certainty evidence). Magnesium sulfate had little or no effect on death up to 2 years of corrected age (moderate-certainty evidence) or these outcomes at school age (low-certainty evidence). Although there was little or no effect on death or cardiac or respiratory arrest for pregnant individuals (low-certainty evidence), magnesium sulfate increased adverse effects severe enough to stop treatment (RR 3.21, 95% CI, 1.88-5.48; three RCTs, 4,736 participants; moderate-certainty evidence). Secondary outcome: magnesium sulfate reduced the risk of severe neonatal intraventricular hemorrhage (moderate-certainty evidence).

Conclusion: Magnesium sulfate for preterm fetal neuroprotection reduces cerebral palsy and death or cerebral palsy for children. Further research is required on longer-term benefits and harms for children, effect variation by participant and treatment characteristics, and the generalizability of findings to low- and middle-income countries.

Systematic review registration: The review protocol was based on a standard Cochrane Pregnancy and Childbirth template and our previous Cochrane Systematic Review (doi: 10.1002/14651858.CD004661.pub3 ; published before the introduction of PROSPERO).