American Journal of Obstetrics & Gynecology Mfm最新文献

Objective

Data Source

Study Eligibility Criteria

Methods

Results

Conclusion

Background

Induction of labor (IOL) with mechanical methods or pharmacological agents is used in about 20% to 30% of all pregnant women. We specialized in comparing the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix with adequate samples.

Objective

To compare the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix.

Study Design

This is a parallel, open-label randomized controlled trial in two maternal centers in Shanghai, China between October 2019 and July 2022. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score <6) scheduled for IOL were eligible. A total of 1860 women were randomly allocated to cervical ripening with either a dinoprostone vaginal insert (10 mg) or a 60 cc Foley catheter for up to 24 hours. The primary outcomes were vaginal delivery rate and time to vaginal delivery. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was done from an intention-to-treat perspective. The trial was registered with the China trial registry (CTR2000038435).

Results

The vaginal birth rates were 72.8% (677/930) vs 69.9% (650/930) in vaginal dinoprostone and Foley catheter, respectively (aRR 1.04, 95% confidence interval [CI] 0.98-1.10, risk difference: 0.03). Time to vaginal delivery was not significantly different between the two groups (sub-distribution hazard ratio 1.11, 95% CI 0.99-1.24). Vaginal dinoprostone was more likely complicated with hyperstimulation with fetal heart rate changes (5.8% vs 2.8%, aRR 2.09, 95% CI 1.32-3.31) and placenta abruption (0.9% vs 0.1%, aRR: 8.04, 95% CI 1.01-64.15), while Foley catheter was more likely complicated with suspected intrapartum infection (5.1% vs 8.2%, aRR: 0.62, 95% CI 0.44-0.88) and postpartum infection (1.4% vs 3.7%, aRR: 0.38, 95% CI 0.20-0.72). The composite of poor neonatal outcomes was not significantly different between the two groups (4.5% vs 3.8%, aRR 1.21, 95% CI 0.78-1.88), while more neonatal asphyxia occurred in the dinoprostone group (1.2% vs 0.2%, aRR 5.39, 95% CI 1.22-23.92). In a subgroup analysis, vaginal dinoprostone decreased vaginal birth rate slightly in multiparous women (90.6% vs 97.0%, aRR 0.93, 95% CI 0.88-0.99).

Conclusions

In term pregnant women with an unfavorable cervix, IOL with vaginal dinoprostone or Foley catheter has similar effectiveness. Foley catheter leads to better safety for neonates, while it may result in a higher risk of maternal infection. Furthermore, Foley catheter should be preferred in multiparous women.

BACKGROUND

There is a growing body of evidence indicating that second-degree tears cause both short- and long-term consequences. Very few preventative measures have been found to reduce the incidence of these tears.

OBJECTIVE

This study aimed to investigate whether the use of a perineal protection device during vaginal birth reduces severe perineal tearing (grade ≥2 tear) in primiparous women compared with routine manual perineal support.

STUDY DESIGN

A single-center randomized controlled trial was conducted in Sweden from 2019 to 2021. Primiparous women at term were randomly allocated to the intervention group (n=43), where a perineal protection device was used, or to the routine care group (n=49). The primary outcome was grade of perineal tear. The secondary outcomes were vaginal and labial tearing. Continuous data were analyzed using the Student t test or Mann-Whitney U test. Dichotomous data were analyzed using the Pearson X² test, Fisher exact test, and ordinal logistic regression.

RESULTS

Women in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing than those in the control group. The use of the perineal protection device decreased the risk of grade ≥2 tears in relation to grade 0 to 1 tears (odds ratio, 0.40; 95% confidence interval, 0.17–0.94). Ordinal logistic regression analyses revealed an odds ratio of 0.36 (95% confidence interval, 0.16–0.81) per incremetn of grade injury using the perineal protection device vs routine care (P=.013). The number needed to treat using the perineal protection device was 4.3 to avoid 1 grade ≥2 tear. Women in the treatment group showed less labial tearing (P=.016). No adverse effect was detected.

CONCLUSION

The use of a perineal protection device reduced the risk of grade ≥2 perineal tearing by 60% and labial tearing.

BACKGROUND

Postpartum hemorrhage (PPH) is an obstetrical emergency that occurs in 1% to 10% of all deliveries and contributes to nearly one-quarter of all maternal deaths worldwide. Tranexamic acid has been established as an adjunct in the treatment of PPH but its role in its prevention of PPH following vaginal delivery has not been widely studied.

OBJECTIVE

This study aimed to assess the effect of prophylactic tranexamic acid (1 g) along with active management of the third stage of labor in reducing postpartum blood loss and the incidence of postpartum hemorrhage after vaginal delivery.

STUDY DESIGN

In this randomized controlled trial, 650 women with singleton pregnancies at ≥34 weeks of gestation who were undergoing vaginal delivery were included. Eligible women were randomly assigned to receive either 1 g of tranexamic acid or placebo intravenously along with active management of the third stage of labor. Calibrated blood collection bags were used to measure postpartum blood loss during the third and fourth stages of labor.

RESULTS

Of 886 women approached for the study, 650 who met the inclusion criteria were enrolled, and 320 in group A and 321 in group B were analyzed. The maternal characteristics were similar between the groups. The mean blood loss did not differ significantly between the intervention and placebo groups (378.5±261.2 mL vs 383.0±258.9 mL; P=.93). The incidence of primary postpartum hemorrhage was comparable in both groups (15.9% in group A and 15.3% in group B; P=.814). The median quantitative decreases in hemoglobin levels within 12 to 24 hours after delivery were 0.60 g% (interquartile range, 0.40–0.90) in group A and 0.60 g% (interquartile range, 0.40–0.80) in group B, which were comparable in both groups (P=.95). The most common adverse effect reported was dizziness, and there was no thromboembolic event at 3 months follow-up in either group.

Conclusion

The use of tranexamic acid as a prophylactic measure along with active management of the third stage of labor does not provide additional benefit in reducing the postpartum blood loss and incidence of postpartum hemorrhage after vaginal delivery.