[French survey on the management strategy for placenta accreta spectrum]. / Enquête nationale sur la stratégie de prise en charge du placenta accreta en France.

OBJECTIVE: Placenta accreta belongs to placenta accreta spectrum and is defined by an adhesion or even invasion of the placental villi in the myometrium. The main risk factor is a history of cesarean section. Its incidence is increasing following an increase in the cesarean section rate in recent years and the cause of severe maternal morbidity (hemorrhage, transfusions, hysterectomy). Treatment can be radical by cesarean section-hysterectomy or conservative with an attempt at uterine preservation. American, English, Canadian and international recommendations have been established but there are no French recommendations to date. The objective of this study was to investigate management strategy for placenta accreta in type III maternity hospitals in France. MATERIALS AND METHODS: An anonymous questionnaire was sent by email to the obstetrics referents of the university hospital centers in France with type III maternity. RESULTS: Forty-eight centers were approached, with a participation rate of 77%. CONCLUSION: The management of placenta accreta spectrum in France is relatively heterogeneous on several points such as multidisciplinary management, evaluation by placental MRI, preoperative urological evaluation, treatment adopted as first-line, cesarean section-hysterectomy or conservative treatment, therapeutic strategy according to the placental invasion. However, the literature is currently poor, which may explain divergent treatment.

[Spatulas: A Franco-Colombian story or the slow rise of propulsion...] / Les spatules : une histoire franco-colombienne ou la lente ascension de la propulsion .

The idea of using an instrument to assist natural childbirth is not new and it was in the 18th and 19th centuries that the forceps was developed. It is only after the Second World War that the suction cup provides an alternative to instrumental childbirth, but still based on prehension and traction. In 1950, Emile Thierry, in France, presented his spatulas based on the then original principle of propulsion. The diffusion of spatulas is almost non-existent in the Anglo-Saxon world but is not limited to France since its use was real by the Iberians and Latin Americans. There are currently three types of spatula, two of which are French and one Colombian. This review takes up the saga of this instrument for more than 70 years, develops its particularities and describes the present literature.

Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial.

BACKGROUND: Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome. METHODS: We designed a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial in 37 level 3 referral perinatal centres in France. Eligible participants were pregnant women aged 18 years or older with a singleton fetus at risk of preterm delivery and already treated with the first injection of antenatal betamethasone (11·4 mg) before 32 weeks' gestation. We used a computer-generated code producing permuted blocks of varying sizes to randomly assign (1:1) women to receive either a placebo (half-dose group) or a second 11·4 mg betamethasone injection (full-dose group) 24 h later. Randomisation was stratified by gestational age (before or after 28 weeks). Participants, clinicians, and study staff were masked to the treatment allocation. The primary outcome was the need for exogenous intratracheal surfactant within 48 h after birth. Non-inferiority would be shown if the higher limit of the 95% CI for the between-group difference between the half-dose and full-dose groups in the primary endpoint was less than 4 percentage points (corresponding to a maximum relative risk of 1·20). Four interim analyses monitoring the primary and the secondary safety outcomes were done during the study period, using a sequential data analysis method that provided futility and non-inferiority stopping rules and checked for type I and II errors. Interim analyses were done in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT02897076. FINDINGS: Between Jan 2, 2017, and Oct 9, 2019, 3244 women were randomly assigned to the half-dose (n=1620 [49·9%]) or the full-dose group (n=1624 [50·1%]); 48 women withdrew consent, 30 fetuses were stillborn, 16 neonates were lost to follow-up, and 9 neonates died before evaluation, so that 3141 neonates remained for analysis. In the intention-to-treat analysis, the primary outcome occurred in 313 (20·0%) of 1567 neonates in the half-dose group and 276 (17·5%) of 1574 neonates in the full-dose group (risk difference 2·4%, 95% CI -0·3 to 5·2); thus non-inferiority was not shown. The per-protocol analysis also did not show non-inferiority (risk difference 2·2%, 95% CI -0·6 to 5·1). No between-group differences appeared in the rates of neonatal death, grade 3-4 intraventricular haemorrhage, stage ≥2 necrotising enterocolitis, severe retinopathy of prematurity, or bronchopulmonary dysplasia. INTERPRETATION: Because non-inferiority of the half-dose compared with the full-dose regimen was not shown, our results do not support practice changes towards antenatal betamethasone dose reduction. FUNDING: French Ministry of Health.

Alternative to intensive management of the active phase of the second stage of labor: a multicenter randomized trial (Phase Active du Second STade trial) among nulliparous women with an epidural.

BACKGROUND: There is no consensus on an optimal strategy for managing the active phase of the second stage of labor. Intensive pushing could not only reduce pushing duration, but also increase abnormal fetal heart rate because of cord compression and reduced placental perfusion and oxygenation resulting from the combination of uterine contractions and maternal expulsive forces. Therefore, it may increase the risk of neonatal acidosis and the need for operative vaginal delivery. OBJECTIVE: This study aimed to assess the effect of the management encouraging "moderate" pushing vs "intensive" pushing on neonatal morbidity. STUDY DESIGN: This study was a multicenter randomized controlled trial, including nulliparas in the second stage of labor with an epidural and a singleton cephalic fetus at term and with a normal fetal heart rate. Of note, 2 groups were defined: (1) the moderate pushing group, in which women had no time limit on pushing, pushed only twice during each contraction, and observed regular periods without pushing, and (2) the intensive pushing group, in which women pushed 3 times during each contraction and the midwife called an obstetrician after 30 minutes of pushing to discuss operative delivery (standard care). The primary outcome was a composite neonatal morbidity criterion, including umbilical arterial pH of <7.15, base excess of >10 mmol/L, lactate levels of >6 mmol/L, 5-minute Apgar score of <7, and severe neonatal trauma. The secondary outcomes were mode of delivery, episiotomy, obstetrical anal sphincter injuries, postpartum hemorrhage, and maternal satisfaction. RESULTS: The study included 1710 nulliparous women. The neonatal morbidity rate was 18.9% in the moderate pushing group and 20.6% in the intensive pushing group (P=.38). Pushing duration was longer in the moderate group than in the intensive group (38.8±26.4 vs 28.6±17.0 minutes; P<.001), and its rate of operative delivery was 21.1% in the moderate group compared with 24.8% in the intensive group (P=.08). The episiotomy rate was significantly lower in the moderate pushing group than in the intensive pushing group (13.5% vs 17.8%; P=.02). We found no significant difference for obstetrical anal sphincter injuries, postpartum hemorrhage, or maternal satisfaction. CONCLUSION: Moderate pushing has no effect on neonatal morbidity, but it may nonetheless have benefits, as it was associated with a lower episiotomy rate.

Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial.

BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.

Second stage cesarean section and the risk of preterm birth in subsequent pregnancies.

OBJECTIVE: To evaluate the risk of spontaneous preterm birth on subsequent pregnancies after second stage cesarean section. METHODS: This is a retrospective cohort study. Women were included if they had their two consecutive births in Toulouse University Hospital in the study period. The first birth was a singleton livebirth at term (≥37 weeks of gestation), divided in three categories according to the mode of delivery: vaginal delivery (group A), cesarean section before the second stage of labor (group B), cesarean section during the second stage of labor (group C). The subsequent pregnancy was the first subsequent pregnancy, conducted after 16 weeks of gestation. The primary outcome was spontaneous preterm birth in the subsequent pregnancy, defined as delivery before 37 weeks of gestation. Secondary endpoints included preterm rupture of membranes in the subsequent pregnancy. RESULTS: Between 2003 and 2018, 7776 women (84.7%) in group A, 1263 (13.8%) in group B and 143 (1.5%) in group C were included. The adjusted odds ratio of spontaneous preterm birth before 37 weeks of gestation after second stage cesarean section was 2.4 (group C vs group A + B, 95% confidence interval: 1.2-4.8), P = 0.01). The rate of preterm rupture of membranes was also significantly higher in group C (6% vs 2% in group A, P = 0.009, 6% vs 3% in group B, P= 0.05) with OR = 3.0 (group C vs group A + B, 95% CI: 1.55-6.16, P < 0.001). CONCLUSION: History of term second stage of labor cesarean section is an independent risk factor for spontaneous preterm birth and for preterm rupture of membrane in the subsequent pregnancy.

Maternal and neonatal morbidity after forceps or spatulas-assisted delivery in preterm birth.

OBJECTIVE: The aim of this study was to assess perinatal morbidity associated with spatulas or forceps assisted delivery in preterm birth. STUDY DESIGN: This is a retrospective cohort study including all women with assisted deliveries on singleton pregnancy in cephalic presentation, before 37 weeks of gestation, in two tertiary care centers. We compared forceps-assisted deliveries with spatula-assisted deliveries. The main outcome was the rate of neonatal birth trauma. Secondary outcomes included other neonatal parameters, maternal outcomes and obstetric anal sphincter injuries. RESULTS: Out of 37 002 deliveries, 59 (0.2 %) preterm assisted deliveries with forceps and 111 (0.3%) preterm spatulas deliveries were included. The rate of neonatal birth trauma was low for both devices, without significant difference (3.4% in Forceps group vs 0.9% in Spatulas group, p = 0.28). The rate of episiotomy was 79.7% after forceps-assisted delivery and 48.6% for spatulas (p < 0.001). The rate of obstetric anal sphincter injuries was 1.7% and 2.7% respectively (p = 0,9). CONCLUSION: The rate of birth trauma was low in both forceps-assisted deliveries and spatula-assisted deliveries and was not significantly different between the two groups.

Identifying predictive factors for admitting patients with severe pre-eclampsia to intensive care unit.

BACKGROUND: Traditional obstetric units are inadequate for the level of monitoring required in pre-eclamptic patients. It remains to be determined which facility and tools should be implemented. The aim of this work was to identify predictive factors of admission to Intensive Care Unit (ICU) admissions for pregnancy-related hypertensive complications. METHODS: We conducted an observational, retrospective multicenter study (Toulouse, Nantes). Both have a level III maternity unit and an ICU. The selected patients had one or more of the following diagnoses on admission in the ICU or during hospitalization: pre-eclampsia, eclampsia, HELLP syndrome, Acute Fatty Liver of Pregnancy (AFLP), Hemolytic Uremic Syndrome (HUS). SAPS II, SOFA and APACHE II on admission, and a validated nursing workload assessment score: TISS 28, were collected. RESULTS: 211 parturient women were included. According to the multivariate analysis: APACHE II and SAPS 2 severity scores >15 were significantly higher in the TISS 28 ≥ 20 group. There were also higher rates of uricemia >360 mmol/l. CONCLUSIONS: To date, there are no reliable and validated predictive factors of severity to guide the transfer of pre-eclamptic patients to an ICU. The combination of an increased APACHE II score and uricemia, as well as a high care workload score that could help with the transfer of high-risk pre-eclamptic patients to a specific care facility. This hypothesis should be tested prospectively. This work could incite reflection on the value of creating obstetric intensive care units, according to the size of the maternity unit.

Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).

A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA).

BACKGROUND: We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA). METHODS: A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study. RESULTS: Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women. CONCLUSION: We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery. TRIAL REGISTRATION: The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).