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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00545194
• Date of registration: 16/10/2007
• Prospective Registration: No
• Primary sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Public title: Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
• Scientific title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
• Date of first enrolment: January 2002
• Target sample size: 446
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00545194
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Franck Perrotin, MD-PhD
• Affiliation: Tours Universiity Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Ripening

Labor, Induced

Intervention(s)

Drug: Prostaglandin E2

Primary Outcome(s)

Percentage of vaginal deliveries within the 48 hours after cervical ripening [Time Frame: 48 hours]

Secondary Outcome(s)

Arterial base excess more than 12 [Time Frame: 48 hours]

Time to reach 3cm cervical dilatation [Time Frame: 48 hours]

Apgar score at 5 min less or equal 7 [Time Frame: 48 hours]

Arterial pH less or equal 7.20 [Time Frame: 48 hours]

Number of hypertonia with or without fetal heart rate monitoring abnormalities [Time Frame: 48 hours]

Apgar score at 10 min less or equal 7 [Time Frame: 48 hours]

Number of maternal post-partum haemorrhage [Time Frame: 48 hours]

Vaginal deliveries at 12 hours, 24 hours and 36 hours [Time Frame: 48 hours]

Proportion of total vaginal deliveries [Time Frame: 48 hours]

Number of hyperkinesia with or without fetal heart rate monitoring abnormalities [Time Frame: 48 hours]

Secondary ID(s)

PROPESS Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors