Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol

NCT ID: NCT03748147

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2021-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We will perform a prospective, randomized, double-blind clinical trial with parallel assignment.

Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor Affected Fetus / Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Standard of care, misoprostol 25 mcg po every four hours

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

prostaglandin e1

Intervention

Misoprostol 50 mcg po every four hours

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

prostaglandin e1

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Misoprostol

prostaglandin e1

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cytotec

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carri Warshak

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carri R Warshak, M.D.

Role: CONTACT

513-558-8448

David McKinney, M.D.

Role: CONTACT

513-558-8448

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-4435

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.