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

This study is currently recruiting participants.
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

January 8, 2013
November 8, 2013
September 2012
September 2014   (final data collection date for primary outcome measure)
Cesarean rate for all indications [ Time Frame: 24h ] [ Designated as safety issue: No ]
Demonstrate that cesarian rate decreases with use of Misoprostol
Same as current
Complete list of historical versions of study NCT01765881 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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

Same as current
 
Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary PGE2: a French Multicentre Randomised Controlled Trial
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 ?

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Benefits of Misoprostol 25 Mcg Vaginally,
  • Efficiency
  • Rate of Cesarean Section,
  • Lower Cost Versus Dinoprostone
  • 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
  • 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
  • Experimental: Misoprostol
    one 25 micrograms capsule all 4 hours by intravaginal route
    Intervention: Drug: Misoprostol
  • Active Comparator: Dinoprostone
    one unique intravaginal sustained released of 10 milligrams
    Intervention: Drug: Dinoprostone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
September 2015
September 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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
France
 
NCT01765881
1014301, 2011-000933-35
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Christophe Vayssière, PhD University Hospital, Toulouse
Principal Investigator: Patrick Rozenberg, MD IH Poissy
Principal Investigator: Romain Favre, MD Strasbourg Hospital
University Hospital, Toulouse
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP