Clinical trial NCT03018860: Alternative to Intensive Management of the Active Phase of the Second Stage of Labor
Official title: Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Active Second Stage
Keywords: Active second stage
Neonatal morbidity
Operative delivery
Labor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-01-12
Enrollment: 1701
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neonatal morbidity composite measure
timeFrame: at childbirth
Secondary outcomes:
measure: Mode of delivery
timeFrame: at childbirth
measure: Immediate postpartum complications
timeFrame: 2 hours after delivery
measure: Immediate postpartum complications
timeFrame: 2 hours after delivery
measure: Immediate postpartum complications
timeFrame: 2 hours after delivery
measure: Immediate postpartum complications
timeFrame: 2 hours after delivery
measure: Immediate postpartum complications
timeFrame: 2 hours after delivery
measure: Women satisfaction assessed with the Labour Agentry scale
timeFrame: 2 hours after delivery
measure: Women satisfaction assessed with the ICIQ-UI Short Form
timeFrame: 6 months post partum
measure: Urinary and anal incontinence assessed with the Wexner Score
timeFrame: 6 months post partum
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Yves ANCEL, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.
citation: Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.
citation: Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.
citation: Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.
citation: Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.
citation: Le Ray C, Rozenberg P, Kayem G, Harvey T, Sibiude J, Doret M, Parant O, Fuchs F, Vardon D, Azria E, Senat MV, Ceccaldi PF, Seco A, Garabedian C, Chantry AA; Groupe de Recherche en Obstetrique et Gynecologie. 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. Am J Obstet Gynecol. 2022 Oct;227(4):639.e1-639.e15. doi: 10.1016/j.ajog.2022.07.025. Epub 2022 Jul 19.