Phase 2
N=374
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
Cervical Ripening · Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT00828711 ↗Enrolled (actual)
374
Serious AEs
35.6%
Results posted
Apr 2014
Primary outcome: Primary: Proportion of Women Delivering Vaginally — 63.75; 66.67; 76.00 percentage of participants — p=0.057
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MVI 100 (Drug); MVI 150 (Drug); MVI 200 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Women Delivering Vaginally |
63.75; 66.67; 76.00 | 0.057 |
| SECONDARY Time to Vaginal Delivery |
1744; 1535; 1181 | 0.018 sig |
| SECONDARY Rate of Adverse Events |
81.4; 80.0; 79.4; 28.0; 27.2; 32.1 | — |
| SECONDARY Proportion of Cesarean Delivery |
31.36; 30.40; 22.90 | 0.153 |
| SECONDARY Cervical Ripening Using Composite Measure of Success |
77.78; 77.60; 80.15 | 0.65 |
| SECONDARY Use of Oxytocin |
70.94; 60.00; 48.85 | <.001 sig |
| SECONDARY Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid. |
NA; NA | — |
| SECONDARY Time to Onset of Active Labor |
1069.00; 775.00; 701.00 | 0.007 sig |
Summary
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.
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 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 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.
Data sourced from ClinicalTrials.gov (NCT00828711). 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.