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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00828711
Other study ID # Miso-Obs-204
Secondary ID
Status Completed
Phase Phase 2
First received January 22, 2009
Last updated March 10, 2014
Start date April 2009
Est. completion date December 2009

Study information

Verified date March 2014
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States University of New Mexico Medical Center Albuquerque New Mexico
United States Duke University Medical Center Durham North Carolina
United States Greenville Hospital System Greenville South Carolina
United States University of Texas Health Sciences Center at Houston Houston Texas
United States University of Tennesse Medical Center Knoxville Tennessee
United States Long Beach Memorial Medical Center Long Beach California
United States UCI Medical Center Orange California
United States Temple University Hospital Philadelphia Pennsylvania
United States Precision Trials Phoenix Arizona
United States Tuscon Medical Center Tucson Arizona
United States Forsyth Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Women Delivering Vaginally Interval from study drug administration to 24 hours No
Secondary Time to Vaginal Delivery Interval from study drug administration to delivery (average 24 hours) No
Secondary Rate of Adverse Events 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. From study drug administration to hospital discharge (approximately 48 - 72 hours) Yes
Secondary Proportion of Cesarean Delivery Interval from study drug administration to cesarean delivery (average 24 hours) Yes
Secondary Cervical Ripening Using Composite Measure of Success 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.
12 hours after insertion of drug No
Secondary Use of Oxytocin Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure. At least 30 minutes after study drug removal No
Secondary Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid. 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. From study drug insertion up to 2 hours post study drug removal No
Secondary Time to Onset of Active Labor Interval from study drug administration to active labor (average 12 hours) No
See also
  Status Clinical Trial Phase
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT01139801 - Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon N/A
Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
Completed NCT04529837 - Ultrasound Assessment of DILAPAN-S
Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Completed NCT02098421 - Foley Labor Induction Trial at Term and in PROM Phase 1
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A