The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women ...with vaginal delivery would decrease the incidence of postpartum hemorrhage.
In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag.
Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval CI, 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24).
Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).
Abstract Objective To assess the frequency and determinants of medical interventions during childbirth without women's consent at the population level. Methods The nationwide cross‐sectional Enquête ...Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2‐month postpartum follow‐up ( n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2‐month attrition. Results Women reporting failure to seek consent were 44.7% (CI: 42.6–47.0) for oxytocin administration, 60.2% (CI: 55.4–65.0) for episiotomy, and 36.6% (CI: 33.3–40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio aPR 1.20; 95% CI: 1.06–1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68–0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11–1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13–1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28–1.96). Conclusion Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women's involvement in decision making during childbirth.
Synopsis Women often report that professionals do not seek their consent for interventions during childbirth. Care reorganization and specific training are needed to improve birth experience.
Introduction
Since the 1970s, fetal scalp blood sampling (FSBS) has been used as a second‐line test of the acid–base status of the fetus to evaluate fetal well‐being during labor. The commonly ...employed thresholds that delineate normal pH (>7.25), subnormal (7.20–7.25), and pathological pH (<7.20) guide clinical decisions. However, these experienced‐based thresholds, based on observations and common sense, have yet to be confirmed. The aim of the study was to investigate if pH drop rate accelerates at the common thresholds (7.25 and 7.20) and to explore the possibility of identifying more accurate thresholds.
Material and methods
A retrospective study was conducted at a tertiary maternity hospital between June 2017 and July 2021. Patients with at least one FSBS during labor for category II fetal heart rate and delivery of a singleton cephalic infant were included. The rate of change in pH value between consecutive samples for each patient was calculated and plotted as a function of pH value. Linear regression models were used to model the evolution of the pH drop rate estimating slope and standard errors across predefined pH intervals. Exploration of alternative pH action thresholds was conducted. To explore the independence of the association between pH value and pH drop rate, multiple linear regression adjusted on age, body mass index, parity, oxytocin stimulation and suspected small for gestational age was performed.
Results
We included 2047 patients with at least one FSBS (total FSBS 3467); with 2047 umbilical cord blood pH, and a total of 5514 pH samples. Median pH values were 7.29 1 h before delivery, 7.26 30 min before delivery. The pH drop was slow between 7.40 and 7.30, then became more pronounced, with median rates of 0.0005 units/min at 7.25 and 0.0013 units/min at 7.20. Out of the alternative pH thresholds, 7.26 and 7.20 demonstrated the best alignment with our dataset. Multiple linear regression revealed that only pH value was significantly associated to the rate of pH change.
Conclusions
Our study confirms the validity and reliability of current guideline thresholds for fetal scalp pH in category II fetal heart rate.
The fetal scalp pH intervention thresholds during labor have been defined empirically 50 years ago. This study provides a scientific basis for using those thresholds by confirming their validity and reliability for fetal scalp pH in category II FHR.
Introduction
Our objective was to identify factors associated with episiotomy practice in France, in particular, characteristics of the maternity units and regions of delivery.
Material and methods
...We performed a national cross‐sectional population‐based study in all French maternity units in 2016 including 9284 women with vaginal delivery. Our outcome was the performance of an episiotomy. After stratification for parity, associations of episiotomy practice with individual and organizational characteristics and the region of delivery were estimated with multilevel logistic regression models. The variability in maternity unit episiotomy rates explained by the characteristics studied was estimated by the proportional change in variance.
Results
A total of 19.9% of the women had an episiotomy. The principal factors associated with episiotomy practice were maternal and obstetric and delivery in a maternity unit with <2000 annual deliveries. After adjusting for individual, obstetric and organizational characteristics, the practice of episiotomy was strongly associated with women's region of delivery. Additionally, women's individual characteristics did not explain the significant variability in episiotomy rates between maternity units (P < 0.001) but maternity unit characteristics partly did (proportion of variance explained: 7.2% for primiparas and 13.6% for multiparas) and regional differences still more (18% and 30.7%, respectively).
Conclusions
Episiotomy practices in France in 2016 varied strongly between maternity units, largely due to regional differences. Targeted actions by the regional perinatal care networks may reduce the national episiotomy rate and standardize practices.
In the French National Perinatal Survey, maternity unit characteristics in part and regional differences especially explained episiotomy rate variability.
Abstract Objective International migration from source countries has meant that clinicians in high income countries, that is, receiving countries, are increasingly caring for affected women affected ...by female genital mutilation/cutting (FGM/C). The aim of the present study was to assess the prevalence of FGM/C among women at childbirth, and its association with pregnancy outcomes. Methods This was an observational study using data from a cross‐sectional population‐based study from the French National Perinatal Survey of 2021 (ENP) conducted in all maternity units in mainland France and including all women delivering a live birth during 1 week in March 2021 ( N = 10 928). We estimated the FGM/C prevalence using (i) the diagnosed cases and (ii) the indirect prevalence estimated by UNICEF in each source country. We compared population characteristics and perinatal outcomes between women diagnosed with FGM/C and two groups: (i) women originating in source countries and diagnosed as without FGM/C and (ii) all women without diagnosis of FGM/C whatever the country of birth. Results Diagnosed prevalence of FGM/C was 95% (95% CI: 0.78–1.14 and the indirect computed estimation prevalence was estimated at 1.53% (95% CI: 1.31–1.77) in 113 and 183 women, respectively. Labor and delivery outcomes were globally similar in women with FGM/C and the other two groups. Only episiotomy was more frequently performed in women with FGM/C than in the other two groups. Conclusion In receiving countries, obstetric outcomes of women with FGM/C can be similar to those of other women, which does not preclude need of further research and training to provide the most appropriate care, including enhanced attention to diagnosis.
Synopsis In receiving countries, obstetric outcomes of women with genital mutilation/cutting can be similar to those of other women.
To evaluate whether the decrease in the frequency of oxytocin administration and artificial rupture of membranes observed between the 2010 and 2016 French Perinatal Surveys was associated with a ...change in the frequency of cesarean delivery or cesarean delivery indications among women who entered labor spontaneously.
This cross-sectional study included women who participated in the 2010 and 2016 French National surveys who had singleton pregnancies and who gave birth at at least 37 weeks of gestation after spontaneous labor to a liveborn neonate in cephalic presentation. To test whether the observed decrease of oxytocin administration and artificial rupture of membranes between the two study years was explained by the women's individual characteristics and maternity units' organizational characteristics change, multivariable analyses were performed. The same strategy was applied for the change in intrapartum cesarean delivery rates between the 2 years. These analyses were repeated in nulliparous, low obstetric risk women, multiparous low obstetric risk women, and women with a previous cesarean delivery. The cesarean delivery indications were compared in 2010 and 2016.
Oxytocin administration decreased significantly from 58.3% in 2010 to 45.2% in 2016 (adjusted odds ratio aOR 0.51; 95% CI 0.47-0.55), as did artificial rupture of membranes, from 52.4% to 42.6% (aOR 0.66; 95% CI 0.62-0.71). The intrapartum cesarean delivery rate remained stable-6.9% compared with 6.6% (aOR 0.93; 95% CI 0.82-1.06). The same patterns were observed in low risk groups and women with a previous cesarean delivery. The cesarean delivery indications were similar in both years.
The significant decrease in oxytocin administration and artificial rupture of membranes in 2016 compared with 2010 was not accompanied by an increase in the intrapartum cesarean delivery rate for women in France who entered labor spontaneously. These results support the recent international guidelines.
Background
In many countries the closure of small maternity units has raised concerns about how the concentration of low‐risk pregnancies in large specialized units might affect the management of ...childbirth. We aimed to assess the role of maternity unit characteristics on obstetric intervention rates among low‐risk women in France.
Methods
Data on low‐risk deliveries came from the 2010 French National Perinatal Survey of a representative sample of births (n = 9,530). The maternity unit characteristics studied were size, level of care, and private or public status; the interventions included induction of labor; cesarean section; operative vaginal delivery (forceps, spatulas or vacuum); and episiotomy. Multilevel logistic regression analyses were adjusted for maternal confounding factors, gestational age, and infant birthweight.
Results
The rates of induction, cesarean section, operative delivery, and episiotomy in this low‐risk population were 23.9 percent, 10.1 percent, 15.2 percent, and 19.6 percent, respectively, and 52.0 percent of deliveries included at least one of them. Unit size was unrelated to any intervention except operative delivery (adjusted odds ratio aOR = 1.47 (95% CI, 1.10–1.96) for units with >3,000 deliveries per year vs units with <1,000). The rate of every intervention was higher in private units, and the aOR for any intervention was 1.82 (95% CI, 1.59–2.08). After adjustment for maternal characteristics and facility size and status, significant variations in the use of interventions remained between units, especially for episiotomies. Results for level of care were similar to those for unit size.
Conclusions
The concentration of births in large maternity units in France is not associated with higher rates of interventions for low‐risk births. The situation in private units could be explained by differences in the organization of care. Additional research should explore the differences in practices between maternity units with similar characteristics. (BIRTH 39:3 September 2012)
Given contradictory evidence about preterm birth (PTB) decreases during COVID-19 lockdowns, we investigate PTB rates during France's strict nationwide lockdown (March 17, 2020 to May 10, 2020).
This ...is an interrupted time series analysis using data on maternal delivery hospitalizations in France from January 01, 2016 to July 31, 2020 (3,448,286 singleton births ≥22 weeks’ gestational age (GA)). Outcomes were weekly PTB rates (overall and by GA sub-group: <28, 28–31, 32–34, 35–36 weeks), stillbirth and cesarean birth. We estimate odds ratios (OR) using the lockdown period as exposed and other weeks as unexposed, nationally and for districts grouped by COVID-19 incidence.
Of 96,076 singleton live births during the lockdown, 4,799 were preterm. PTB rates were 6% (OR: 0.94, 95% CI: 0.90–0.98) lower than expected over this period. This decrease occurred among births 35–36 weeks’ GA (OR: 0.92, 95% CI: 0.87–0.98), with no detectable reductions for other GA groups. Cesarean and stillbirth rates were stable. Larger differences were observed in districts with low (OR: 0.92, 95% CI 0.87–0.98) versus moderate/high COVID-19 incidence (OR: 0.97, 95% CI 0.92–1.03).
Late preterm births decreased during France's first lockdown without concurrent change in cesareans and stillbirths. Effects were not more pronounced in moderate/high-COVID-19 districts, contradicting expectations if healthcare disruption were a principal cause.
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