Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00308711
First received: March 27, 2006
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.


Condition Intervention Phase
Cervical Ripening
Labor, Induced
Drug: Misoprostol vaginal insert 100 mcg
Drug: Misoprostol vaginal insert 50 mcg
Drug: Dinoprostone vaginal insert (Cervidil)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor (The MVP Study).

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Minutes From Drug Insertion to Vaginal Delivery [ Time Frame: 2880 minutes ] [ Designated as safety issue: No ]
    Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.

  • Percentage of Participants With a Cesarean Section Delivery [ Time Frame: 2880 minutes ] [ Designated as safety issue: Yes ]
    Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.


Secondary Outcome Measures:
  • Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
    This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods.

  • Percentage of Participants With Pre-Delivery Oxytocin Use [ Time Frame: 2880 minutes ] [ Designated as safety issue: No ]
    Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.

  • Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.

  • Minutes to Onset of Active Labor [ Time Frame: 2880 minutes ] [ Designated as safety issue: No ]
    Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.

  • Minutes to Rupture of Membranes (ROM) [ Time Frame: 2880 minutes ] [ Designated as safety issue: No ]
    Interval from study drug insertion to ROM.

  • Duration of Stay in Minutes in Labor and Delivery Suite [ Time Frame: 5760 minuts ] [ Designated as safety issue: No ]
    Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.

  • Days in Hospital for Mother and Neonate [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.


Enrollment: 1308
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MVI 100
Misoprostol vaginal insert 100 mcg over 24h
Drug: Misoprostol vaginal insert 100 mcg
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Other Name: Misopess(TM)
Experimental: MVI 50
Misoprostol vaginal insert 50 mcg over 24h
Drug: Misoprostol vaginal insert 50 mcg
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Other Name: Misopess(TM)
Active Comparator: Cervidil 10 mg vaginal insert
Cervidil 10 mg over 24h
Drug: Dinoprostone vaginal insert (Cervidil)
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Other Names:
  • Propess(R)
  • 10 mg dinoprostone vaginal insert

Detailed Description:

Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.

The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.

Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor

Exclusion Criteria:

  • No uterine scar (no previous delivery by cesarean section)
  • No multiple gestation
  • No condition that disallows use of prostaglandins for induction of labor
  • No more than 3 previous vaginal births beyond 24 weeks gestation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308711

  Show 52 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Helen Colquhoun, MD
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00308711     History of Changes
Other Study ID Numbers: Miso-Obs-004
Study First Received: March 27, 2006
Results First Received: July 29, 2009
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Cervical ripening
Induction of labor
Dinoprostone vaginal insert
Cervidil
Misoprostol vaginal insert
Modified Bishop's Score
PGE2
PGE1
Uterine Hyperstimulation
Cesarean section

Additional relevant MeSH terms:
Dinoprostone
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 18, 2014