Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2 (CYTOPRO)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: January 8, 2013
Last updated: November 25, 2015
Last verified: November 2015
For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication . It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone.

Condition Intervention Phase
Delivery Uterine
Drug: Misoprostol
Drug: Dinoprostone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary Prostaglandin-E2 (PGE2) : Could we Used Low Dose Vaginal Misoprostol as a First Line Treatment for Induction of Labor ?

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Cesarean rate for all indications [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Demonstrate that cesarian rate decreases with use of Misoprostol

Secondary Outcome Measures:
  • Cost-effectiveness of two strategies (direct medical cost differential efficiency strategies measured by the Cesarean rate [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Tolerance of two strategies Misoprostol/ Dinoprostone [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

    Tolerance of two strategies:

    Maternal hyperstimulation syndrome rate, rate of postpartum hemorrhage, maternal satisfaction.

    neonatal rate of pH <7.05 and BD> 12mmol / L, rates Apgar score <7 at 5 minutes, transfer rate in neonatal intensive-care unit (NICU)

Enrollment: 1700
Study Start Date: September 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Misoprostol
one 25 micrograms capsule all 4 hours by intravaginal route
Drug: Misoprostol
administration of Misoprostol 25 micrograms capsule by intravaginal route all 4 hours
Other Names:
  • 25 micrograms Misoprostol capsule by intravaginal route
Active Comparator: Dinoprostone
one unique intravaginal sustained released of 10 milligrams
Drug: Dinoprostone
administration of one sustained released capsule of 10 milligrams by intravaginal route
Other Names:
  • one intravaginal sustained released capsule of 10 milligrams

Detailed Description:
To show if the experimental treatment (25μg of intravaginal misoprostol) used for induction of labor in singleton women ≥ 36 weeks gestation with an unfavorable cervix is not clinically and statistically inferior than the reference treatment , ie intravaginal dinoprostone sustained release (10mg), to compare the cost-effectiveness and to assess the differential tolerance of the two strategies.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • singleton pregnancy
  • Cephalic presentation
  • Bishop ≤ 5
  • ≤ 3 uterine contractions / 10 mn
  • ≥ 36 weeks gestation

Exclusion Criteria:

  • uterine scar
  • deceleration on Cardiotocogram (CTG)
  • placenta praevia
  • bleeding
  • chorioamnionitis
  • Fetal weight US ≥4500 g
  Contacts and Locations
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Please refer to this study by its identifier: NCT01765881

Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94000
Hospital Poissy
Poissy, France, 78303
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: Christophe Vayssière, MD PhD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse Identifier: NCT01765881     History of Changes
Other Study ID Numbers: 1014301  2011-000933-35 
Study First Received: January 8, 2013
Last Updated: November 25, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
Induction of labor
cervical ripening

Additional relevant MeSH terms:
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on February 09, 2016