Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
This study has been completed.
Sponsored by: Institut National de la Santé Et de la Recherche Médicale, France
Information provided by: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00545194
  Purpose

The aim of this study is to compare two different preparation


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

Drug Information available for: Dinoprostone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

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
A: Active Comparator
sustained release preparation of prostaglandin E2
Drug: Prostaglandin E2
B: Active Comparator
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
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:
Lyrenas 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.

Study ID Numbers: PROPESS Study
Study First Received: October 16, 2007
Last Updated: October 16, 2007
ClinicalTrials.gov Identifier: NCT00545194  
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

Study placed in the following topic categories:
Dinoprostone

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

ClinicalTrials.gov processed this record on January 14, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services