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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01765881
First received: January 8, 2013
Last updated: April 26, 2016
Last verified: March 2016

January 8, 2013
April 26, 2016
September 2012
September 2015   (final data collection date for primary outcome measure)
Cesarean for all indications [ Time Frame: Up to delivery ] [ Designated as safety issue: No ]
Occurrence of cesarean section for all indications
Cesarean rate for all indications [ Time Frame: 24h ] [ Designated as safety issue: No ]
Demonstrate that cesarian rate decreases with use of Misoprostol
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: Up to discharge / end of study ] [ Designated as safety issue: No ]
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 ]
  • Adverse events [ Time Frame: Up to discharge/end of study ] [ Designated as safety issue: Yes ]
    Summary description of all adverse events, related adverse events and serious adverse events by treatment using MedRA classification.
  • Other specific safety assessments [ Time Frame: Up to discharge/end of study ] [ Designated as safety issue: Yes ]
    Maternal hyperstimulation syndromes with or without changes of foetal heart rate, uterine hypertonus, rate, rate of postpartum hemorrhage, degree III/IV perineal tears, uterine rupture, neonatal rate of pH <7.05 and/or BDbase deficit> 12mmol / L, rates Apgar score <7 at 5 minutes, transfer rate in neonatal intensive-care unit (NICU), neonatal seizures
  • Other efficacy assessments [ Time Frame: Up to discharge/end of study ] [ Designated as safety issue: No ]
    Time from 1st treatment administration to delivery, ocytocine administration and dose, occurrence of instrumental delivery, occurrence of spontaneous delivery
  • Participant satisfaction assessment [ Time Frame: Up to discharge/end of study ] [ Designated as safety issue: No ]
    Maternal satisfaction using visual analog scale and questionnaire
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

 
Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2
Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary Prostaglandin-E2 (PGE2) : Could we Use 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.

The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs. dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5% difference.

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), in terms of cesarian sectionto compare the cost-effectiveness and to assess the differential tolerance of the two strategies.

Non-inferiority will be demonstrated if the upper limit of the 90%-bilateral confidence interval of the difference between cesarian section rates (misoprostol - dinosprostone) is below 5% in the intention-to-treat analysis and the per-protocol analysis.

If non-inferiority is demonstrated, as a secondary analysis, superiority of misosprostol will be tested.

Orther secondary objectives are to assess the cost-effectiveness, the tolerance, maternal satisfaction and other efficacy endpoints of the two strategies.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Delivery Uterine
  • Drug: Misoprostol
    administration of Misoprostol 25 micrograms capsule by intravaginal route every 4 hours, up to 4 capsules
    Other Names:
    • CYTOTEC
    • 25 micrograms Misoprostol capsule by intravaginal route
  • Drug: Dinoprostone
    administration of one sustained released pessary 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.
 
Completed
1700
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • singleton pregnancy
  • Cephalic presentation
  • Bishop ≤ 5
  • ≤ 3 uterine contractions / 10 mn
  • ≥ 36 weeks gestation
  • Personally signed and dated informed consent document

Exclusion Criteria:

  • History of cesarian-section
  • uterine scar
  • deceleration on Cardiotocogram (CTG)
  • placenta praevia
  • bleeding
  • chorioamnionitis
  • Fetal weight US ≥4500 g
  • Contra-indication to vaginal delivery
  • Hystory of myomectomy
  • Herpes primoinfection or recurrence
  • Allergy to prostaglandins
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01765881
1014301, 2011-000933-35
No
No
Not Provided
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Christophe Vayssière, MD PhD University Hospital, Toulouse
University Hospital, Toulouse
March 2016

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