Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (EXPEDITE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01127581
First received: May 19, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Reducing Time to Vaginal Delivery
Cervical Ripening
Induction of Labor
Drug: MVI 200
Drug: Dinoprostone Vaginal Insert (DVI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Time to Vaginal Delivery During the First Hospital Admission [ Time Frame: Interval from study drug administration to vaginal delivery (average 24 hours) ] [ Designated as safety issue: No ]
  • Incidence of Cesarean Delivery During the First Hospital Admission [ Time Frame: Interval from study drug administration to cesarean delivery (average 24 hours) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission [ Time Frame: Interval from study drug administration to neonate delivery (average 24 hours) ] [ Designated as safety issue: No ]
  • Time to Active Labor During the First Hospital Admission [ Time Frame: Interval from study drug administration to active labor (average 12 hours) ] [ Designated as safety issue: No ]
    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.

  • Incidence of Pre-delivery Oxytocin During the First Hospital Admission [ 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.

  • Incidence of Vaginal Delivery Within 12 Hours [ Time Frame: Interval from study drug administration to vaginal delivery within 12 hours ] [ Designated as safety issue: No ]
  • Incidence of Any Delivery Within 24 Hours [ Time Frame: Interval from study drug administration to delivery of neonate within 24 hours ] [ Designated as safety issue: No ]
  • Incidence of Any Delivery Within 12 Hours [ Time Frame: Interval from study drug administration to delivery of neonate within 12 hours ] [ Designated as safety issue: No ]
  • Incidence of Vaginal Delivery Within 24 Hours [ Time Frame: Interval from study drug administration to vaginal delivery within 24 hours ] [ Designated as safety issue: No ]
  • Incidence of Vaginal Delivery [ Time Frame: Interval from study drug administration to vaginal 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.


Enrollment: 1358
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MVI 200
MVI 200 mcg vaginal insert
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)
Active Comparator: Dinoprostone Vaginal Insert (DVI)
10 mg Dinoprostone vaginal insert
Drug: 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.
Other Names:
  • Cervidil (R)
  • Propess (R)

  Eligibility

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

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.
  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: NCT01127581

  Show 34 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01127581     History of Changes
Other Study ID Numbers: Miso-Obs-303
Study First Received: May 19, 2010
Results First Received: January 24, 2014
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Misoprostol vaginal insert
Dinoprostone vaginal insert
Cervidil
Cervical ripening
Induction of labor
Rate of 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 28, 2014