Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics - Full Text View

Sponsors and Collaborators:	University of California, Irvine Long Beach Memorial Medical Center
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00514618

Purpose

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:

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.
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.)
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.

Condition	Intervention
Diabetes, Gestational	Drug: Misoprostol Dietary Supplement: Placebo

MedlinePlus related topics: Diabetes

Drug Information available for: Ascorbic acid Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Outpatient Cervical Ripening and Labor Induction With Orally Administered Misoprostol for Term Pregnancies Complicated by Diabetes Mellitus

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

The primary outcome measure will be the time interval from start of induction to delivery. [ Time Frame: induction to delivery ]

Secondary Outcome Measures:

Other outcome measures will be number of doses of medication required, oxytocin requirements, and route of delivery. [ Time Frame: induction to delivery ]

Estimated Enrollment:	128
Study Start Date:	March 2006
Estimated Study Completion Date:	February 2009

Arms	Assigned Interventions
1: Active Comparator patients will be treated with misoprostol 50 g PO	Drug: Misoprostol patients will be treated with misoprostol 50 g PO q day for two days (days 1 and 4)
2: Placebo Comparator patients will receive placebo (Vitamin C)	Dietary Supplement: Placebo patients will receive placebo (vitamin C) q day for two days (days 1 and 4)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Singleton gestation
Intact membranes
Bishop score  4
Uterine contractions ≤12/hour
Cephalic presentation
Estimated gestational age of at least 38 weeks by ACOG dates
An amniotic fluid index (AFI) >5 cm
Reactive Non Stress Test
Class A1, A2 diabetes
Good compliance with clinic visits and home glucose monitoring

Exclusion Criteria:

I. Fetal Factors

Multiple Gestation
Presence of fetal distress/non-reassuring FHR pattern
Malpresentation, including breech
EFW > 4500 gm or other evidence of cephalo-pelvic disproportion
EFW < 2000 gm

II. Maternal Factors

Frequent uterine contractions  12/hour
Ruptured membranes
Placenta previa or unexplained vaginal bleeding
Vasa previa
Active herpes simplex
Glaucoma or elevated intraocular pressure
Renal or hepatic dysfunction
Previous Cesarean delivery or history of uterine surgery
Evidence of chorioamnionitis or maternal fetal  100.4F
Significant cardiac lesion or cardiovascular disease
Severe asthma
Parity  6

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514618

Contacts

Contact: Christine Preslicka, RN

562-933-2755

cpreslicka@memorialcare.org

Locations

United States, California
Long Beach Memorial Medical Center	Recruiting
Long Beach, California, United States, 90806
Contact: Christine Preslicka, RN 562-933-2755 cpreslicka@memorialcare.org

Sponsors and Collaborators

University of California, Irvine

Long Beach Memorial Medical Center

Investigators

Principal Investigator:

Deborah A Wing, MD

University of California, Irvine

More Information

Study ID Numbers:	334-06
Study First Received:	August 9, 2007
Last Updated:	August 9, 2007
ClinicalTrials.gov Identifier:	NCT00514618
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Irvine:

Term Pregnancy
Diabetes
Cervical Ripening

Induction
misoprostol
Term Gestational Diabetics

Study placed in the following topic categories:

Pregnancy Complications
Metabolic Diseases
Misoprostol
Diabetes Mellitus
Endocrine System Diseases

Diabetes, Gestational
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Ascorbic Acid

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009