Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Long Beach Memorial Medical Center
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00514618
First received: August 9, 2007
Last updated: April 4, 2011
Last verified: April 2011
  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:

  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Outpatient Cervical Ripening and Labor Induction With Orally Administered Misoprostol for Term Pregnancies Complicated by Diabetes Mellitus

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
patients will be treated with misoprostol 50 mcg PO
Drug: Misoprostol
patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4)
Other Name: Cytotec
Placebo Comparator: 2
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:

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

Exclusion Criteria:

I. Fetal Factors

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

II. Maternal Factors

  1. Frequent uterine contractions >= 12/hour
  2. Ruptured membranes
  3. Placenta previa or unexplained vaginal bleeding
  4. Vasa previa
  5. Active herpes simplex
  6. Glaucoma or elevated intraocular pressure
  7. Renal or hepatic dysfunction
  8. Previous Cesarean delivery or history of uterine surgery
  9. Evidence of chorioamnionitis or maternal fetal >= 100.4 degrees F
  10. Significant cardiac lesion or cardiovascular disease
  11. Severe asthma
  12. Parity >=6
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
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

No publications provided

Responsible Party: Christine Preslicka, LBMMC
ClinicalTrials.gov Identifier: NCT00514618     History of Changes
Other Study ID Numbers: 334-06
Study First Received: August 9, 2007
Last Updated: April 4, 2011
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014