Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545194
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : October 17, 2007
Sponsor:
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is to compare two different preparation

Condition or disease Intervention/treatment Phase
Cervical Ripening Labor, Induced Drug: Prostaglandin E2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2002
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. Proportion of total vaginal deliveries [ Time Frame: 48 hours ]
  2. Vaginal deliveries at 12 hours, 24 hours and 36 hours [ Time Frame: 48 hours ]
  3. Number of hyperkinesia with or without fetal heart rate monitoring abnormalities [ Time Frame: 48 hours ]
  4. Number of hypertonia with or without fetal heart rate monitoring abnormalities [ Time Frame: 48 hours ]
  5. Apgar score at 5 min less or equal 7 [ Time Frame: 48 hours ]
  6. Apgar score at 10 min less or equal 7 [ Time Frame: 48 hours ]
  7. Arterial pH less or equal 7.20 [ Time Frame: 48 hours ]
  8. Arterial base excess more than 12 [ Time Frame: 48 hours ]
  9. Number of maternal post-partum haemorrhage [ Time Frame: 48 hours ]
  10. Time to reach 3cm cervical dilatation [ Time Frame: 48 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545194


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Franck Perrotin, MD-PhD Tours Universiity Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00545194    
Other Study ID Numbers: PROPESS Study
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: October 17, 2007
Last Verified: October 2007
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:
Layout table for MeSH terms
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs