NCT02408315

Brief Summary

The primary objective of this study is to compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0 completed weeks gestation. Thus, the investigators have both efficacy and a safety primary outcomes. The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with these two routes of administration in a sub-cohort of this trial. The long term objective of this line of research is to inform providers' clinical decision making for the large number of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation, clinical outcomes data for these two routes of administration, clinicians will be informed for evidence-based decisions about the preferred route of administration of misoprostol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P25-P50 for phase_3 pregnancy

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_3 pregnancy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 9, 2019

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 13, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

February 10, 2015

Results QC Date

May 22, 2019

Last Update Submit

March 28, 2022

Conditions

Pregnancy

Keywords

induction of laborsafetypharmacokineticmisoprostol

Outcome Measures

Primary Outcomes (2)

  • Time to Delivery

    number of hours from placement of study drug to delivery Cesarean delivery for fetal non--reassurance indication

    from study entry until delivery- anticipated 3 days

  • Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications

    Rate of cesarean deliveries performed for fetal non-reassurance as the indication

    from study entry until delivery- anticipated 3 days

Secondary Outcomes (7)

  • Number of Vaginal Deliveries That Occurred Within 24 Hours

    from study entry until delivery- anticipated 3 days

  • Number of Participants Who Had Uterine Hyperstimulation

    from study entry until delivery- anticipated 3 days

  • Number of Neonatal Intensive Care Unit (NICU) Admission

    from study entry until discharge of newborn- anticipated up to 28 days

  • Number of Doses Misoprostol Used

    from study entry until delivery- anticipated 3 days

  • Uterine Rupture

    from study entry until delivery- anticipated 3 days

  • +2 more secondary outcomes

Other Outcomes (2)

  • Pharmacokinetic Profiling of Misoprostol

    from study entry until delivery- anticipated 3 days

  • Participant Satisfaction

    from study entry until discharge- anticipated 5 days

Study Arms (2)

misoprostol/placebo using buccal

PLACEBO COMPARATOR

Randomized for buccal route of administration/ placebo

Drug: misoprostol/placebo

misoprostol/placebo using vaginal

PLACEBO COMPARATOR

Randomized for vaginal route of administration/ placebo

Drug: misoprostol/placebo

Interventions

misoprostol/placeboDRUG

buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.

Also known as: Cytotec
misoprostol/placebo using buccalmisoprostol/placebo using vaginal

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A medical indication for induction of labor at a gestational age between 37 +0 and 38 +6 weeks OR an elective or medical indication for induction of labor at a gestational age greater than or equal to 39 + 0 completed weeks
  • Participant age of greater than or equal to14 years old
  • Singleton pregnancy
  • Modified Bishop score of less than or equal to 6
  • Vertex fetal presentation by examination or ultrasound
  • Any membrane status

You may not qualify if:

  • Elective inductions between 37 +0 and 38 +6 completed weeks are specifically excluded
  • Known intrauterine fetal demise
  • Any uterine scar including prior cesarean section and myomectomy
  • Known major fetal congenital malformations that may impact neonatal health
  • Other evidence of fetal compromise (such as Category 2 or 3 tracing) before the induction begins
  • Prior induction/cervical ripening methods utilized during this pregnancy
  • Allergy to misoprostol
  • Known untreated cervical infection (e.g. Gonorrhea, Chlamydia)
  • Planned cesarean section due to maternal or fetal condition
  • Any other contraindication to labor induction or misoprostol therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

  • Nassar AH, Awwad J, Khalil AM, Abu-Musa A, Mehio G, Usta IM. A randomised comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labour at term. BJOG. 2007 Oct;114(10):1215-21. doi: 10.1111/j.1471-0528.2007.01492.x.

    PMID: 17877674BACKGROUND

  • Vorontsova Y, Haas DM, Flannery K, Masters AR, Silva LL, Pierson RC, Yeley B, Hogg G, Guise D, Heathman M, Quinney SK. Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term. Clin Transl Sci. 2022 Aug;15(8):1937-1945. doi: 10.1111/cts.13306. Epub 2022 Jun 12.

    PMID: 35587540DERIVED

  • Haas DM, Daggy J, Flannery KM, Dorr ML, Bonsack C, Bhamidipalli SS, Pierson RC, Lathrop A, Towns R, Ngo N, Head A, Morgan S, Quinney SK. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial. Am J Obstet Gynecol. 2019 Sep;221(3):259.e1-259.e16. doi: 10.1016/j.ajog.2019.04.037. Epub 2019 May 7.

    PMID: 31075246DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Dr. David M. Haas
Organization
Indiana University School of Medicine
dahaas@iu.edu
317-880-3949

Study Officials

  • David M Haas, MD

    IU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Vice Chair for Research

Study Record Dates

First Submitted

February 10, 2015

First Posted

April 3, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2017

Study Completion

December 1, 2021

Last Updated

April 13, 2022

Results First Posted

July 9, 2019

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Will share as needed for IPD.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After study completion and for 1 year after
Access Criteria
Email contact to study contact.

Locations

US(2)