Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (EXPEDITE)

Ferring

Status and phase

Completed

Phase 3

Conditions

Cervical Ripening

Reducing Time to Vaginal Delivery

Induction of Labor

Treatments

Drug: MVI 200

Drug: Dinoprostone Vaginal Insert (DVI)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01127581

Miso-Obs-303

Details and patient eligibility

About

The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.

Enrollment

1,358 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent;
Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Women aged 18 years or older;
Candidate for pharmacological induction of labor;
Single, live vertex fetus;
Baseline modified Bishop score ≤ 4;
Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion criteria

Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
Fetal malpresentation;
Diagnosed congenital anomalies, not including polydactyly;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
Ruptured membranes ≥ 48 hours prior to the start of treatment;
Suspected chorioamnionitis;
Fever (oral or aural temperature > 37.5°C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.