Study of the Type of Pushing at Delivery (NCT02474745) | Clinical Trial Compass
CompletedNot Applicable
Study of the Type of Pushing at Delivery
France256 participantsStarted 2015-07
Plain-language summary
The objective of this randomized clinical trial is to assess and compare the effectiveness of directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs. directed open-glottis pushing (pushing during a prolonged exhalation) during the second stage of labor. The study hypothesis is that open-glottis pushing results in better maternal and neonatal outcomes, in particular for maternal pelvic floor and continence function.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients will be women:
* who are nulliparas or multiparas (≥ 1 previous child),
* who attended the complete training session on the types of pushing assessed in this trial; during prenatal childbirth preparation and parenthood classes (regardless of the type of prenatal preparation)
* for whom a vaginal delivery was planned at the end of pregnancy,
* admitted to the maternity ward between 37 and 42 weeks of gestation (≥ 37 weeks and ≤ 42 weeks) in spontaneous or induced labor,
* with cervical dilatation ≥ 7 cm,
* with a singleton pregnancy in cephalic presentation,
* who provided informed consent in writing
* and speaks and writes French.
Exclusion Criteria:
* Women who are :
* minors,
* adults but incapable of providing consent for the study,
* with a disorder contraindicating prolonged pushing,
* with a uterine scar (previous cesarean or other surgery),
* with a contraindication to vaginal delivery,
* with a maternal disease that could justify in the short-term termination of the pregnancy (HELLP syndrome, preeclampsia \[hypertension with albuminuria \> 0.3 g by 24 hours\], eclampsia, abruptio placentae, etc.),
* with a major genital hemorrhage,
* with a major fetal malformation and/or hydramnios or oligohydramnios, and/or FGR (\<5°percentile), diagnosed in utero,
* with a fetal heart rate anomaly before randomization,
* with an in utero fetal death,
* with a multiple pregnancy.
What they're measuring
1
composite criterion: spontaneous delivery without perineal lesion