Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

NCT01765881 | Completed Phase 2

• 2 other identifiers: 10143012011-000933-35
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 4

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.

Conditions

Delivery Uterine

Keywords

Induction of labor; cervical ripening; misoprostol,; prostaglandin; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Cesarean for all indications

  Occurrence of cesarean section for all indications

  Up to delivery

Secondary Outcomes (1)

• Cost-effectiveness of two strategies (direct medical cost differential efficiency strategies measured by the Cesarean rate

  Up to discharge / end of study

Other Outcomes (4)

• Adverse events

  Up to discharge/end of study

• Other specific safety assessments

  Up to discharge/end of study

• Other efficacy assessments

  Up to discharge/end of study

Study Arms (2)

Misoprostol

EXPERIMENTAL

one 25 micrograms capsule all 4 hours by intravaginal route

Drug: Misoprostol

Dinoprostone

ACTIVE COMPARATOR

one unique intravaginal sustained released of 10 milligrams

Drug: Dinoprostone

Interventions

Misoprostol DRUG

administration of Misoprostol 25 micrograms capsule by intravaginal route every 4 hours, up to 4 capsules

Also known as: CYTOTEC, 25 micrograms Misoprostol capsule by intravaginal route

Misoprostol

Dinoprostone DRUG

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

Also known as: PROPESS, one intravaginal sustained released capsule of 10 milligrams

Dinoprostone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

University Hospital Toulouse

Toulouse, France, 31059, France

Location

Bicêtre Hospital

Le Kremlin-Bicêtre, 94000, France

Location

Hospital Poissy

Poissy, 78303, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (2)

• Mounie M, Costa N, Gaudineau A, Molinier L, Vayssiere C, Derumeaux H. Cost-effectiveness analysis of vaginal misoprostol versus dinoprostone pessary: A non-inferiority large randomized controlled trial in France. Int J Gynaecol Obstet. 2022 Aug;158(2):390-397. doi: 10.1002/ijgo.13999. Epub 2021 Nov 19.

  PMID: 34714938 DERIVED

• Gaudineau A, Senat MV, Ehlinger V, Gallini A, Morin M, Olivier P, Roth E, Orusco E, Javoise S, Fort J, Lavergne C, Arnaud C, Rozenberg P, Vayssiere C; Groupe de Recherche en Obstetrique rt Gynecologie. Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):542.e1-542.e8. doi: 10.1016/j.ajog.2021.04.226. Epub 2021 Apr 19.

  PMID: 33887241 DERIVED

MeSH Terms

Interventions

Misoprostol; Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E

Study Officials

• Christophe Vayssière, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 10, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)