Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor

Ferring

Status and phase: Completed; Phase 2

Conditions: Cervical Ripening; Induction of Labor

Treatments: Drug: MVI 100; Drug: MVI 150; Drug: MVI 200

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828711

Miso-Obs-204

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.

Enrollment: 374 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 pharmacologic 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

• Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
• 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 fetal abnormalities;
• Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
• 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, other prostaglandins or any of the excipients;
• Any condition urgently requiring delivery;
• Unable to comply with the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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374 participants in 3 patient groups

MVI 100

Experimental group

Description:

MVI 100 mcg vaginal insert

Treatment:

Drug: MVI 100

MVI 150

Experimental group

Description:

MVI 150 mcg vaginal insert

Treatment:

Drug: MVI 150

MVI 200

Experimental group

Description:

MVI 200 mcg vaginal insert

Treatment:

Drug: MVI 200