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Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics

NCT00514618 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-11-07

Study results available
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Summary

A. Null Hypothesis:

In term pregnancies complicated by diabetes, there is no difference in the time interval from start of induction to delivery when outpatient cervical ripening and labor induction is initiated with orally administered misoprostol, a prostaglandin El analogue, compared to placebo.

B. Specific aims:

1. Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus.
2. Demonstrate that oral misoprostol can be administered safely in an outpatient setting. The patients will be observed for a period of four hours in an outpatient antepartum testing unit after the medication is administered to demonstrate fetal well being and verify that there is no evidence of uterine hyperstimulation. (We acknowledge that markers of serious adverse maternal and neonatal outcomes are rare, and can only be adequately addressed in large multicenter trials.)
3. Assess the cost differential in inpatient and outpatient utilization of misoprostol for cervical ripening and labor induction. In order to estimate the impact that outpatient cervical ripening may have on total hospitalization costs, we will use daily hospital charges and published data regarding pharmaceutical costs.

Conditions

  • Diabetes, Gestational

Interventions

DRUG

Misoprostol

patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4)

DIETARY_SUPPLEMENT

Placebo

patients will receive placebo (vitamin C) q day for two days (days 1 and 4)

Sponsors & Collaborators

  • Long Beach Memorial Medical Center

    collaborator OTHER

  • MemorialCare Health System

    lead OTHER

Principal Investigators

  • Deborah A Wing, MD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00514618 on ClinicalTrials.gov