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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00828711
First received: January 22, 2009
Last updated: March 10, 2014
Last verified: March 2014

January 22, 2009
March 10, 2014
April 2009
December 2009   (final data collection date for primary outcome measure)
Proportion of Women Delivering Vaginally [ Time Frame: Interval from study drug administration to 24 hours ] [ Designated as safety issue: No ]
Proportion of women delivering vaginally [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828711 on ClinicalTrials.gov Archive Site
  • Time to Vaginal Delivery [ Time Frame: Interval from study drug administration to delivery (average 24 hours) ] [ Designated as safety issue: No ]
  • Rate of Adverse Events [ Time Frame: From study drug administration to hospital discharge (approximately 48 - 72 hours) ] [ Designated as safety issue: Yes ]
    All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.
  • Proportion of Cesarean Delivery [ Time Frame: Interval from study drug administration to cesarean delivery (average 24 hours) ] [ Designated as safety issue: Yes ]
  • Cervical Ripening Using Composite Measure of Success [ Time Frame: 12 hours after insertion of drug ] [ Designated as safety issue: No ]

    Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:

    • Increase from baseline in modified Bishop score ≥3; or
    • Achievement of modified Bishop score of ≥6; or
    • Vaginal delivery.
  • Use of Oxytocin [ Time Frame: At least 30 minutes after study drug removal ] [ Designated as safety issue: No ]
    Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.
  • Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid. [ Time Frame: From study drug insertion up to 2 hours post study drug removal ] [ Designated as safety issue: No ]
    The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.
  • Time to Onset of Active Labor [ Time Frame: Interval from study drug administration to active labor (average 12 hours) ] [ Designated as safety issue: No ]
  • Time to vaginal delivery [ Time Frame: Interval from insertion to delivery ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Proportion of cesarean delivery [ Time Frame: after insertion of study drug ] [ Designated as safety issue: Yes ]
  • Cervical ripening using composite measure of success [ Time Frame: 6, 12, 18 and 24h after insertion of drug ] [ Designated as safety issue: No ]
  • Vaginal delivery [ Time Frame: Within 12h after drug insertion ] [ Designated as safety issue: No ]
  • Use of oxytocin [ Time Frame: after study drug removal ] [ Designated as safety issue: No ]
  • pharmacokinetics [ Time Frame: During study drug insertion and after removal ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
A Multicenter, Randomized, Double-Blind, Dose-Ranging, Phase II Study to Assess the Efficacy and Safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert for Women Requiring Cervical Ripening and Induction of Labor

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cervical Ripening
  • Induction of Labor
  • Drug: MVI 100
    Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
    Other Names:
    • Misopess (TM)
    • Misodel (R)
  • Drug: MVI 150
    Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
    Other Names:
    • Misopess (TM)
    • Misodel (R)
  • Drug: MVI 200
    Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
    Other Names:
    • Misopess (TM)
    • Misodel (R)
  • Experimental: MVI 100
    MVI 100 mcg vaginal insert
    Intervention: Drug: MVI 100
  • Experimental: MVI 150
    MVI 150 mcg vaginal insert
    Intervention: Drug: MVI 150
  • Experimental: MVI 200
    MVI 200 mcg vaginal insert
    Intervention: Drug: MVI 200
Wing DA, Miller H, Parker L, Powers BL, Rayburn WF; Misoprostol Vaginal Insert Miso-Obs-204 Investigators. Misoprostol vaginal insert for successful labor induction: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):533-41. doi: 10.1097/AOG.0b013e318209d669.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828711
Miso-Obs-204
Yes
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP