Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01127581
Other study ID # Miso-Obs-303
Secondary ID
Status Completed
Phase Phase 3
First received May 19, 2010
Last updated April 15, 2014
Start date September 2010
Est. completion date March 2012

Study information

Verified date April 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 determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.


Recruitment information / eligibility

Status Completed
Enrollment 1358
Est. completion date March 2012
Est. primary completion date March 2012
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 pharmacological 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:

- 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 congenital anomalies, not including polydactyly;

- Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);

- Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;

- 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, dinoprostone, 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 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.
Dinoprostone Vaginal Insert (DVI)
Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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/New Mexico Health Science Center Albuquerque New Mexico
United States University of Michigan Hospital Ann Arbor Michigan
United States Medical University of South Carolina Charleston South Carolina
United States UT College of Medicine Chattanooga, Erlanger Health System Chattanooga Tennessee
United States University of Cincinnati Cincinnati Ohio
United States Duke University Medical Center Durham North Carolina
United States Clinical Trials of America Eugene Oregon
United States The Women's Clinic of Northern Colorado Fort Collins Colorado
United States Spectrum Health Grand Rapids Michigan
United States East Carolina University, Brody School of Medicine Greenville North Carolina
United States University Medical Group/Greenville Hospital System Greenville South Carolina
United States University of Texas Health Sciences Center at Houston Houston Texas
United States Indiana University School of Medicine Indianapolis Indiana
United States University of FL College of Medicine Jacksonville Florida
United States University of Kansas School of Medicine Kansas City Kansas
United States High Risk Obstetrical Consultants, PLLC Knoxville Tennessee
United States Altus Research Lake Worth Florida
United States Miller's Childrens Hospital Long Beach California
United States Marshfield Clinic Research Foundation Marshfield Wisconsin
United States Research Memphis Associates Memphis Tennessee
United States St. Peters University Hospital New Brunswick New Jersey
United States Christiana Care Health System (DE Center for MFM) Newark Delaware
United States UCI Medical Center Orange California
United States Drexel University College of Medicine Philadelphia Pennsylvania
United States Temple University School of Medicine Philadelphia Pennsylvania
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Maricopa Medical Center - District Medical Group Phoenix Arizona
United States Precision Trials Phoenix Arizona
United States Salt Lake Women's Center, PC Sandy Utah
United States Phoenix Perinatal Associates (Scottsdale Healthcare Shea) Scottsdale Arizona
United States St. Louis University St. Louis Missouri
United States University of South Florida Tampa Florida
United States Watching Over Mothers and Babies Foundation Tucson Arizona
United States Lyndhurst Gynecologic Associates 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 Time to Vaginal Delivery During the First Hospital Admission Interval from study drug administration to vaginal delivery (average 24 hours) No
Primary Incidence of Cesarean Delivery During the First Hospital Admission Interval from study drug administration to cesarean delivery (average 24 hours) Yes
Secondary Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission Interval from study drug administration to neonate delivery (average 24 hours) No
Secondary Time to Active Labor During the First Hospital Admission Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more. Interval from study drug administration to active labor (average 12 hours) No
Secondary Incidence of Pre-delivery Oxytocin During the First Hospital Admission Percentage of participants in receipt of Oxytocin for induction after study drug removal. At least 30 minutes after study drug removal No
Secondary Incidence of Vaginal Delivery Within 12 Hours Interval from study drug administration to vaginal delivery within 12 hours No
Secondary Incidence of Any Delivery Within 24 Hours Interval from study drug administration to delivery of neonate within 24 hours No
Secondary Incidence of Any Delivery Within 12 Hours Interval from study drug administration to delivery of neonate within 12 hours No
Secondary Incidence of Vaginal Delivery Within 24 Hours Interval from study drug administration to vaginal delivery within 24 hours No
Secondary Incidence of Vaginal Delivery Interval from study drug administration to vaginal 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. From study drug administration to hospital discharge (approximately 48-72 hours) Yes
See also
  Status Clinical Trial Phase
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 NCT02098421 - Foley Labor Induction Trial at Term and in PROM Phase 1
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
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
Completed NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb Early Phase 1