Effect of the Type of Maternal Pushing During the Second Stage of Labor on Obstetric and Neonatal Outcome: a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- composite criterion: spontaneous delivery without perineal lesion
研究概览
简要总结
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.
详细描述
This is a multicenter randomized, clinical trial: directed closed-glottis pushing (pushing while holding one's breath) vs. directed open-glottis pushing (pushing during a prolonged exhalation) during the active phase of labor during which the fetus descends through the birth canal (second stage).
Study plan and procedures:
During prenatal care visits, women will be informed about the study by posters hung in maternity units and midwives' offices.
All participating staff - that is, all professionals teaching childbirth preparation and parenthood classes who agree to participate in the study and midwives, who will include and randomize the women and will then manage the delivery -- will be trained in advance in both pushing techniques so that they can teach and support the women. A video intended specifically for professionals will be produced for the study and will make it possible to standardize the instruction that the professionals provide the women about each type of pushing.
Midwives (both hospital-based and in private practice) who lead childbirth preparation and parenthood classes will inform women of the study's existence. During one class session, pregnant women will receive structured instruction, including a video specifically created for the women in the study, describing both types of directed pushing. They will also have access to this training video, which will be available online at the website of the Auvergne perinatal health network (https://www.auvergne-perinat.org/). They will also receive a written brochure about the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Women who are :
- •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.
研究组 & 干预措施
INTERVENTION GROUP
Directed open-glottis pushing (with prolonged exhalation) must be explained to the women and professionals as follows:
"After inhaling deeply, the patient will exhale while pulling in her stomach in such a way they she can use the contraction of her abdominal muscles to help the fetus descend through the birth control. She should push as long as possible
干预措施: - Directed open-glottis pushing (Procedure)
CONTROL GROUP
Directed closed-glottis pushing (pushing while holding one's breath) should be explained to the women and professionals as follows:
"After inhaling deeply, the patient should push very hard downwards to the perineum, while holding the inhaled breath in her lungs. She should push as hard and as long as possible."
干预措施: Directed closed-glottis pushing (Procedure)
结局指标
主要结局
composite criterion: spontaneous delivery without perineal lesion
时间窗: at day 1
(episiotomy, spontaneous 2nd, 3rd or 4th degree lacerations).
次要结局
- occurrence of perineal lesions such as episiotomy or a severe perineal laceration(at day 1)
- effect on pelvic floor and urinary function (POP-Q and ICIQ-SF)(at 2 months after delivery or at the postpartum visit)
- women's satisfaction by a Swiss validated questionnaire(at 4 weeks postpartum)
- immediate postpartum hemorrhage(at day 1)