NCT02474745

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

June 5, 2015

Last Update Submit

April 16, 2026

Conditions

Delivery2nd Stage of Labor

Keywords

second stage of laborpushing techniques

Outcome Measures

Primary Outcomes (1)

  • composite criterion: spontaneous delivery without perineal lesion

    (episiotomy, spontaneous 2nd, 3rd or 4th degree lacerations).

    at day 1

Secondary Outcomes (4)

  • occurrence of perineal lesions such as episiotomy or a severe perineal laceration

    at day 1

  • immediate postpartum hemorrhage

    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

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

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

Procedure: - Directed open-glottis pushing

CONTROL GROUP

OTHER

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."

Procedure: Directed closed-glottis pushing

Interventions

- Directed open-glottis pushingPROCEDURE

Description of the intervention in the 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" Description of the intervention in the 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."

INTERVENTION GROUP
Directed closed-glottis pushingPROCEDURE

Description of the intervention in the 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" Description of the intervention in the 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."

CONTROL GROUP

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (3)

  • Barasinski C, Lemery D, Vendittelli F. Do maternal pushing techniques during labour affect obstetric or neonatal outcomes? Gynecol Obstet Fertil. 2016 Oct;44(10):578-583. doi: 10.1016/j.gyobfe.2016.07.004. Epub 2016 Aug 24.

    PMID: 27568414RESULT

  • Barasinski C, Debost-Legrand A, Savary D, Bouchet P, Curinier S, Vendittelli F. Does the type of pushing at delivery influence pelvic floor function at 2 months postpartum? A pragmatic randomized trial-The EOLE study. Acta Obstet Gynecol Scand. 2023 Jan;102(1):67-75. doi: 10.1111/aogs.14461. Epub 2022 Nov 9.

    PMID: 36352788DERIVED

  • Barasinski C, Vendittelli F. Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial-the EOLE study protocol. BMJ Open. 2016 Dec 20;6(12):e012290. doi: 10.1136/bmjopen-2016-012290.

    PMID: 27998899DERIVED

Study Officials

  • Chloé BARASINSKI

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 18, 2015

Study Start

July 1, 2015

Primary Completion

June 14, 2017

Study Completion

June 14, 2017

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)