Phase 3
N=1,358
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
Reducing Time to Vaginal Delivery · Cervical Ripening · Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT01127581 ↗Enrolled (actual)
1,358
Serious AEs
17.5%
Results posted
Mar 2014
Primary outcome: Primary: Time to Vaginal Delivery During the First Hospital Admission — 1292.00; 1968.50 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MVI 200 (Drug); Dinoprostone Vaginal Insert (DVI) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Vaginal Delivery During the First Hospital Admission |
1292.00; 1968.50 | <0.001 sig |
| PRIMARY Incidence of Cesarean Delivery During the First Hospital Admission |
25.96; 27.06 | — |
| SECONDARY Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission |
1096.50; 1639.50 | <0.001 sig |
| SECONDARY Time to Active Labor During the First Hospital Admission |
726.50; 1116.50 | <0.001 sig |
| SECONDARY Incidence of Pre-delivery Oxytocin During the First Hospital Admission |
48.1; 74.1 | <0.001 sig |
| SECONDARY Incidence of Vaginal Delivery Within 12 Hours |
19.76; 8.38 | <0.001 sig |
| SECONDARY Incidence of Any Delivery Within 24 Hours |
67.70; 40.74 | <0.001 sig |
| SECONDARY Incidence of Any Delivery Within 12 Hours |
23.16; 9.26 | <0.001 sig |
| SECONDARY Incidence of Vaginal Delivery Within 24 Hours |
54.57; 33.97 | <0.001 sig |
| SECONDARY Incidence of Vaginal Delivery |
73.30; 71.62 | <0.001 sig |
| SECONDARY Rate of Adverse Events |
55.5; 54.6; 21.4; 21.2; 53.4; 58.1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01127581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.