NCT03748147

Brief Summary

This is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

February 22, 2018

Last Update Submit

November 19, 2018

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • Vaginal delivery

    Successful induction defined as a vaginal delivery following labor induction.

    Variable, but within 4 days

Secondary Outcomes (3)

  • Completed cervical ripening

    2 days

  • Specific time interval from start of induction to active labor

    2 days

  • Rate of tachysystole, fetal nonreassuring status, uterine rupture

    3 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of care, misoprostol 25 mcg po every four hours

Drug: Misoprostol

Intervention

EXPERIMENTAL

Misoprostol 50 mcg po every four hours

Drug: Misoprostol

Interventions

MisoprostolDRUG

prostaglandin e1

Also known as: cytotec
ControlIntervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy, Study of labor induction
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Labor induction, BMI of 30 or greater, English speaking

You may not qualify if:

  • Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Carri R Warshak, M.D.

CONTACT

513-558-8448eaglercr@ucmail.uc.edu

David McKinney, M.D.

CONTACT

513-558-8448mckinndi@ucmail.uc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

November 20, 2018

Study Start

December 10, 2018

Primary Completion

June 1, 2020

Study Completion

March 1, 2021

Last Updated

November 20, 2018

Record last verified: 2018-11