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Completed

NCT Number: NCT03018860

Alternative to Intensive Management of the Active Phase of the Second Stage of Labor

Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75014, France

About this study

Management of the active phase of the second stage of labor is not an evidence-based practice. Management of this phase differs between countries. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.

This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery. In the intervention group, i.e. "moderate" pushing, women are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

The hypothesis is that "moderate" management of the active phase of the second stage allows decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative delivery and increasing maternal satisfaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primiparous women
  • singleton fetus
  • fetal cephalic presentation
  • ≥37 gestational weeks
  • living fetus
  • Patient with epidural analgesia
  • Major Female
  • Women understand French

Exclusion criteria

  • Abnormal fetal heart rate requiring hastening childbirth
  • cervical dilatation < 8 cm
  • intrauterine fetal growth restriction <5e percentile,
  • Fetal malformation,
  • history of gynecological surgery with uterine scar
  • Women do not understand French,
  • women with psychiatric condition
  • contraindication to intensive management of active second stage (severe myopia, respiratory or cardiac failure)
  • no affiliation to a social security scheme (beneficiary or assignee)

Treatment and study plan

"Moderate" management

Procedure

After randomization, women allocated to the intervention group, i.e. "moderate" pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

"Intensive" management

Procedure

This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.

Primary outcomes

  1. Neonatal morbidity composite measure

    Time frame: at childbirth

    number of participant with acidosis arterial cord pH <7.15 and / or excess base> 10 mmol / L and / or lactate> 6 mmol / L and or an Apgar score at 5 minutes <7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes <7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)

Secondary outcomes

  1. Mode of delivery

    Time frame: at childbirth

    spontaneous vaginal, instrumental vaginal delivery or cesarean section

  2. Immediate postpartum complications

    Time frame: 2 hours after delivery

    Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)

  3. Immediate postpartum complications

    Time frame: 2 hours after delivery

    Episiotomy

  4. Immediate postpartum complications

    Time frame: 2 hours after delivery

    Cervical and vaginal lesion

  5. Immediate postpartum complications

    Time frame: 2 hours after delivery

    Severe postpartum hemorrhage (blood loss estimated> 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)

  6. Immediate postpartum complications

    Time frame: 2 hours after delivery

    Postpartum Hemorrhage (blood loss estimated> 500mLand < 1000mL)

  7. Women satisfaction assessed with the Labour Agentry scale

    Time frame: 2 hours after delivery

  8. Women satisfaction assessed with the ICIQ-UI Short Form

    Time frame: 6 months post partum

  9. Urinary and anal incontinence assessed with the Wexner Score

    Time frame: 6 months post partum

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial

Acronym: PASST

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2017
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.