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

Study Overview
=================
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.

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

Conditions
-----------------
Active Second Stage

Intervention / Treatment
-----------------
* Procedure: Moderate management
* Procedure: Intensive management


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate management<br>Women are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration. | Procedure: Moderate management<br>* 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.<br>|
| Active Comparator: Intensive management<br>Usual obstetrical care in France | Procedure: Intensive management<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | spontaneous vaginal, instrumental vaginal delivery or cesarean section | at childbirth | 
| Immediate postpartum complications | Perineal lesions with involvement of the anal sphincter (3rd and 4th degree) | 2 hours after delivery | 
| Immediate postpartum complications | Episiotomy | 2 hours after delivery | 
| Immediate postpartum complications | Cervical and vaginal lesion | 2 hours after delivery | 
| 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 | 
| Immediate postpartum complications | Postpartum Hemorrhage (blood loss estimated> 500mLand < 1000mL) | 2 hours after delivery | 
| Women satisfaction assessed with the Labour Agentry scale |  | 2 hours after delivery | 
| Women satisfaction assessed with the ICIQ-UI Short Form |  | 6 months post partum | 
| Urinary and anal incontinence assessed with the Wexner Score |  | 6 months post partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Operative delivery, Active second stage, Neonatal morbidity, Labor