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

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ClinicalTrials.gov Identifier: NCT00545194
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : October 17, 2007
Sponsor:
Information provided by:

Study Description
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

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
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

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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

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
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
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:
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs