Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary PGE2: a French Multicentre Randomised Controlled Trial (CYTOPRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01765881
First received: January 8, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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
Benefits of Misoprostol 25 Mcg Vaginally,
Efficiency
Rate of Cesarean Section,
Lower Cost Versus Dinoprostone
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 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: No ]

    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 NICU



Estimated Enrollment: 1200
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (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:
  • CYTOTEC
  • introduction of one 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:
  • PROPESS
  • 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.

  Eligibility

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

Inclusion Criteria:

  • ≥ 18 years old
  • singleton pregnancy
  • Cephalic presentation
  • Bishop ≤ 5
  • ≤ 3 uterine contractions / 10 mn
  • ≥ 36 weeks gestation

Exclusion Criteria:

  • uterine scar
  • deceleration on CTG
  • placenta praevia
  • bleeding
  • chorioamnionitis
  • Fetal weight US ≥4500 g
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765881

Contacts
Contact: Christophe Vayssière, MD, PhD 05 67 77 13 79 ext 0033 vayssiere.c@chu-toulouse.fr
Contact: Mathieu Morin, Midwife morin.sf@gmail.com

Locations
France
Vayssière Christophe Recruiting
Toulouse, France, 31059
Contact: Christophe Vayssière, MD, PhD    05 67 77 13 79 ext 0033    vayssiere.c@chu-toulouse.fr   
Contact: Mathieu Morin, Midwife    05 67 74 93 50 ext 0033    morin.sf@gmail.com   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Christophe Vayssière, PhD University Hospital, Toulouse
Principal Investigator: Patrick Rozenberg, MD IH Poissy
Principal Investigator: Romain Favre, MD Strasbourg Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01765881     History of Changes
Other Study ID Numbers: 1014301, 2011-000933-35
Study First Received: January 8, 2013
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Induction of labor
cervical ripening
misoprostol,
prostaglandin
cost-effectiveness

Additional relevant MeSH terms:
Misoprostol
Dinoprostone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 18, 2014