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

This study has been completed.
Sponsor:
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00545194
First received: October 16, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

The aim of this study is to compare two different preparation


Condition Intervention Phase
Cervical Ripening
Labor, Induced
Drug: Prostaglandin E2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 446
Study Start Date: January 2002
Study Completion Date: October 2004
Arms Assigned Interventions
Active Comparator: A
sustained release preparation of prostaglandin E2
Drug: Prostaglandin E2
Active Comparator: B
short-acting (instant-released) preparation of prostaglandin E2
Drug: Prostaglandin E2

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545194

Locations
France
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, France, 37044
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Franck Perrotin, MD-PhD Tours Universiity Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00545194     History of Changes
Other Study ID Numbers: PROPESS Study
Study First Received: October 16, 2007
Last Updated: October 16, 2007
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Prostaglandin E2
Intravaginal gel
Bishop score
Induction of labor
randomized trial
Vaginal insert

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014