Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514618
Recruitment Status : Terminated (Poor enrollment)
First Posted : August 10, 2007
Last Update Posted : April 5, 2011
Long Beach Memorial Medical Center
Information provided by:
University of California, Irvine

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Drug: Misoprostol Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Outpatient Cervical Ripening and Labor Induction With Orally Administered Misoprostol for Term Pregnancies Complicated by Diabetes Mellitus
Study Start Date : March 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
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)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514618

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
Principal Investigator: Deborah A Wing, MD University of California, Irvine

Responsible Party: Christine Preslicka, LBMMC Identifier: NCT00514618     History of Changes
Other Study ID Numbers: 334-06
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by University of California, Irvine:
Term Pregnancy
Cervical Ripening
Term Gestational Diabetics

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