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

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ClinicalTrials.gov Identifier: NCT01127581
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : March 7, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Time to Vaginal Delivery During the First Hospital Admission [ Time Frame: Interval from study drug administration to vaginal delivery (average 24 hours) ]
  2. Incidence of Cesarean Delivery During the First Hospital Admission [ Time Frame: Interval from study drug administration to cesarean delivery (average 24 hours) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Time to Active Labor During the First Hospital Admission [ Time Frame: Interval from study drug administration to active labor (average 12 hours) ]
    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.

  3. Incidence of Pre-delivery Oxytocin During the First Hospital Admission [ Time Frame: At least 30 minutes after study drug removal ]
    Percentage of participants in receipt of Oxytocin for induction after study drug removal.

  4. Incidence of Vaginal Delivery Within 12 Hours [ Time Frame: Interval from study drug administration to vaginal delivery within 12 hours ]
  5. Incidence of Any Delivery Within 24 Hours [ Time Frame: Interval from study drug administration to delivery of neonate within 24 hours ]
  6. Incidence of Any Delivery Within 12 Hours [ Time Frame: Interval from study drug administration to delivery of neonate within 12 hours ]
  7. Incidence of Vaginal Delivery Within 24 Hours [ Time Frame: Interval from study drug administration to vaginal delivery within 24 hours ]
  8. Incidence of Vaginal Delivery [ Time Frame: Interval from study drug administration to vaginal delivery (average 24 hours) ]
  9. Rate of Adverse Events [ Time Frame: From study drug administration to hospital discharge (approximately 48-72 hours) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127581


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

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
First Posted: May 21, 2010    Key Record Dates
Results First Posted: March 7, 2014
Last Update Posted: May 1, 2014
Last Verified: April 2014

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:
Misoprostol
Dinoprostone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics