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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:
ClinicalTrials.gov Identifier:
NCT00545194
First Posted: October 17, 2007
Last Update Posted: October 17, 2007
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.
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
  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
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

Resource links provided by NLM:

Drug Information available for: Dinoprostone
U.S. FDA Resources

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

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.


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:
Lyrenäs S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78.
Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5.
El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30.

ClinicalTrials.gov Identifier: NCT00545194     History of Changes
Other Study ID Numbers: PROPESS Study
First Submitted: October 16, 2007
First Posted: October 17, 2007
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


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