Status:
COMPLETED
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Cervical Ripening
Induction of Labor
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00828711
Start Date
April 1 2009
End Date
December 1 2009
Last Update
April 21 2014
Active Locations (11)
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1
Precision Trials
Phoenix, Arizona, United States, 85032
2
Tuscon Medical Center
Tucson, Arizona, United States, 85716
3
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
4
UCI Medical Center
Orange, California, United States, 92868