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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

Tracking Information
First Submitted Date  ICMJE October 16, 2007
First Posted Date  ICMJE October 17, 2007
Last Update Posted Date October 17, 2007
Study Start Date  ICMJE January 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
Percentage of vaginal deliveries within the 48 hours after cervical ripening [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
Official Title  ICMJE Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
Brief Summary The aim of this study is to compare two different preparation
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Ripening
  • Labor, Induced
Intervention  ICMJE Drug: Prostaglandin E2
Study Arms  ICMJE
  • Active Comparator: A
    sustained release preparation of prostaglandin E2
    Intervention: Drug: Prostaglandin E2
  • Active Comparator: B
    short-acting (instant-released) preparation of prostaglandin E2
    Intervention: Drug: Prostaglandin E2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2007)
446
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00545194
Other Study ID Numbers  ICMJE PROPESS Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franck Perrotin, MD-PhD Tours Universiity Hospital
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP