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

Active Second Stage Clinical Trial

— PASST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018860
• Other study ID #: P150937
• Status: Completed
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: December 7, 2021

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1701
• Est. completion date: December 7, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Active Second Stage

Intervention

Procedure:
• "Moderate" management
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
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.

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. French. — View Citation

Nordström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal morbidity composite measure	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)	at childbirth
Secondary	Mode of delivery	spontaneous vaginal, instrumental vaginal delivery or cesarean section	at childbirth
Secondary	Immediate postpartum complications	Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)	2 hours after delivery
Secondary	Immediate postpartum complications	Episiotomy	2 hours after delivery
Secondary	Immediate postpartum complications	Cervical and vaginal lesion	2 hours after delivery
Secondary	Immediate postpartum complications	Severe postpartum hemorrhage (blood loss estimated> 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)	2 hours after delivery
Secondary	Immediate postpartum complications	Postpartum Hemorrhage (blood loss estimated> 500mLand < 1000mL)	2 hours after delivery
Secondary	Women satisfaction assessed with the Labour Agentry scale		2 hours after delivery
Secondary	Women satisfaction assessed with the ICIQ-UI Short Form		6 months post partum
Secondary	Urinary and anal incontinence assessed with the Wexner Score		6 months post partum