Active Second Stage
Conditions
Keywords
Active second stage, Neonatal morbidity, Operative delivery, Labor
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.
Interventions
PROCEDUREModerate 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.
PROCEDUREIntensive 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.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal morbidity composite measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | at childbirth | spontaneous vaginal, instrumental vaginal delivery or cesarean section |
| Immediate postpartum complications | 2 hours after delivery | Perineal lesions with involvement of the anal sphincter (3rd and 4th degree) |
| 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 | — |
Countries
France
Outcome results
None listed