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

NCT00828711 | Completed Phase 2 Results DMC

• 1 other identifier: Miso-Obs-204
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 11

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 of labor.

Conditions

Cervical Ripening; Induction of Labor

Keywords

Misoprostol vaginal insert; Induction of labor; Cervical ripening; Rate of cesarean section

Outcome Measures

Primary Outcomes (1)

• Proportion of Women Delivering Vaginally

  Interval from study drug administration to 24 hours

Secondary Outcomes (7)

• Time to Vaginal Delivery

  Interval from study drug administration to delivery (average 24 hours)

• Rate of Adverse Events

  From study drug administration to hospital discharge (approximately 48 - 72 hours)

• Proportion of Cesarean Delivery

  Interval from study drug administration to cesarean delivery (average 24 hours)

• Cervical Ripening Using Composite Measure of Success

  12 hours after insertion of drug

• Use of Oxytocin

  At least 30 minutes after study drug removal

Study Arms (3)

MVI 100

EXPERIMENTAL

MVI 100 mcg vaginal insert

Drug: MVI 100

MVI 150

EXPERIMENTAL

MVI 150 mcg vaginal insert

Drug: MVI 150

MVI 200

EXPERIMENTAL

MVI 200 mcg vaginal insert

Drug: MVI 200

Interventions

MVI 100 DRUG

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.

Also known as: Misopess (TM), Misodel (R)

MVI 100

MVI 150 DRUG

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.

Also known as: Misopess (TM), Misodel (R)

MVI 150

MVI 200 DRUG

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.

Also known as: Misopess (TM), Misodel (R)

MVI 200

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (11)

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Tuscon Medical Center

Tucson, Arizona, 85716, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

University of New Mexico Medical Center

Albuquerque, New Mexico, 87131, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

University of Tennesse Medical Center

Knoxville, Tennessee, 37920, United States

Location

University of Texas Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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):533-541. doi: 10.1097/AOG.0b013e318209d669.

  PMID: 21343755 DERIVED

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (11)