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

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ClinicalTrials.gov Identifier: NCT01765881
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Delivery Uterine Drug: Misoprostol Drug: Dinoprostone Phase 2

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), 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 ?
Study Start Date : September 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Misoprostol
one 25 micrograms capsule all 4 hours by intravaginal route
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
Active Comparator: Dinoprostone
one unique intravaginal sustained released of 10 milligrams
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



Primary Outcome Measures :
  1. Cesarean for all indications [ Time Frame: Up to delivery ]
    Occurrence of cesarean section for all indications


Secondary Outcome Measures :
  1. Cost-effectiveness of two strategies (direct medical cost differential efficiency strategies measured by the Cesarean rate [ Time Frame: Up to discharge / end of study ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: Up to discharge/end of study ]
    Summary description of all adverse events, related adverse events and serious adverse events by treatment using MedRA classification.

  2. Other specific safety assessments [ Time Frame: Up to discharge/end of study ]
    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

  3. Other efficacy assessments [ Time Frame: Up to discharge/end of study ]
    Time from 1st treatment administration to delivery, ocytocine administration and dose, occurrence of instrumental delivery, occurrence of spontaneous delivery

  4. Participant satisfaction assessment [ Time Frame: Up to discharge/end of study ]
    Maternal satisfaction using visual analog scale and questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765881


Locations
France
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
Investigators
Principal Investigator: Christophe Vayssière, MD PhD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01765881     History of Changes
Other Study ID Numbers: 1014301
2011-000933-35 ( EudraCT Number )
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics