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Completed

NCT Number: NCT01765881

Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

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.

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Key information

Conditions

Delivery Uterine

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Toulouse, Toulouse, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

Dinoprostone

Drug

administration of one sustained released pessary of 10 milligrams by intravaginal route

Other names: PROPESS, one intravaginal sustained released capsule of 10 milligrams

Primary outcomes

  1. Cesarean for all indications

    Time frame: Up to delivery

    Occurrence of cesarean section for all indications

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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 ?

Acronym: CYTOPRO

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 10, 2013
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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