Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

Delivery Uterine Clinical Trial

— CYTOPRO  

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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765881
• Other study ID #: 1014301
• Secondary ID: 2011-000933-35
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2013
• Last updated: April 26, 2016
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delivery Uterine

Intervention

Drug:
• Misoprostol
administration of Misoprostol 25 micrograms capsule by intravaginal route every 4 hours, up to 4 capsules
• Dinoprostone
administration of one sustained released pessary of 10 milligrams by intravaginal route

Locations

Country	Name	City	State
France	Bicêtre Hospital	Le Kremlin-Bicêtre
France	Hospital Poissy	Poissy
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Summary description of all adverse events, related adverse events and serious adverse events by treatment using MedRA classification.	Up to discharge/end of study	Yes
Other	Other specific safety assessments	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	Up to discharge/end of study	Yes
Other	Other efficacy assessments	Time from 1st treatment administration to delivery, ocytocine administration and dose, occurrence of instrumental delivery, occurrence of spontaneous delivery	Up to discharge/end of study	No
Other	Participant satisfaction assessment	Maternal satisfaction using visual analog scale and questionnaire	Up to discharge/end of study	No
Primary	Cesarean for all indications	Occurrence of cesarean section for all indications	Up to delivery	No
Secondary	Cost-effectiveness of two strategies (direct medical cost differential efficiency strategies measured by the Cesarean rate		Up to discharge / end of study	No