Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics

NCT00514618 | Terminated Results

• 1 other identifier: 334-06 [no UCI HS#]
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Keywords

Term Pregnancy; Diabetes; Cervical Ripening; Induction; misoprostol; Term Gestational Diabetics

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Will be the Time Interval From Start of Induction to Delivery.

  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. The study was terminated, and no study data and/or analyzed. No study data are available.

  induction to delivery

Secondary Outcomes (2)

• Demonstrate That Oral Misoprostol Can be Administered Safely in an Outpatient Setting.

  The PI has left the institution. Efforts were exhausted in attempting to contact the PI/study team members. No study data are available.

• Other Outcome Measures Will be Number of Doses of Medication Required, Oxytocin Requirements, and Route of Delivery.

  induction to delivery

Study Arms (2)

1

ACTIVE COMPARATOR

patients will be treated with misoprostol 50 mcg PO

Drug: Misoprostol

2

PLACEBO COMPARATOR

patients will receive placebo (Vitamin C)

Dietary Supplement: Placebo

Interventions

Misoprostol DRUG

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

Also known as: Cytotec

1

Placebo DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MemorialCare Health System: lead
• Long Beach Memorial Medical Center: collaborator

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

No data was collected.

Results Point of Contact

• Title: Lorna Camfield, Research Compliance Analyst
• Organization: MemorialCare Health Services LBMC

lcamfield@memorialcare.org

714-377-3227

Study Officials

• Deborah A Wing, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 10, 2007
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 7, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-09

Locations

US (1)