Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

NCT ID: NCT01765881

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Delivery Uterine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Misoprostol

one 25 micrograms capsule all 4 hours by intravaginal route

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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

Dinoprostone

one unique intravaginal sustained released of 10 milligrams

Group Type: ACTIVE_COMPARATOR

Dinoprostone

Intervention Type: DRUG

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

Interventions

Misoprostol

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

Intervention Type: DRUG

Dinoprostone

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

Intervention Type: DRUG

Other Intervention Names

CYTOTEC; 25 micrograms Misoprostol capsule by intravaginal route; PROPESS; one intravaginal sustained released capsule of 10 milligrams

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Vayssière, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, France, France

Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Hospital Poissy

Poissy, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34714938 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33887241 (View on PubMed)

Other Identifiers

2011-000933-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1014301

Identifier Type: -

Identifier Source: org_study_id