Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess

Phase 3WithdrawnNCT00545194

Institut National de la Santé Et de la Recherche Médicale, France

Overview

The aim of this study is to compare two different preparation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Cervical Ripening Labor, Induced

Interventions

Prostaglandin E2DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * singleton pregnancy * cephalic presentation * gestation of more than 37 Weeks confirmed by ultrasound * Bishop score less than 7 * Informed consent Exclusion Criteria: * previous cesarean section (scarred uterus) * polyhydramnios * multiple pregnancy * fetal malformation

Locations (1)

Olympe de Gouges Women Health Centre, Bretonneau University Hospital

Tours, France

Outcomes

Primary Outcomes

Percentage of vaginal deliveries within the 48 hours after cervical ripening

Time frame: 48 hours

Secondary Outcomes

Proportion of total vaginal deliveries

Time frame: 48 hours

Vaginal deliveries at 12 hours, 24 hours and 36 hours

Time frame: 48 hours

Number of hyperkinesia with or without fetal heart rate monitoring abnormalities

Time frame: 48 hours

Number of hypertonia with or without fetal heart rate monitoring abnormalities

Time frame: 48 hours

Apgar score at 5 min less or equal 7

Time frame: 48 hours

Apgar score at 10 min less or equal 7

Time frame: 48 hours

Arterial pH less or equal 7.20

Time frame: 48 hours

Arterial base excess more than 12

Time frame: 48 hours

Number of maternal post-partum haemorrhage

Time frame: 48 hours

Time to reach 3cm cervical dilatation

Time frame: 48 hours

Data from ClinicalTrials.gov

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