Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics
Public ClinicalTrials.gov record NCT00514618. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Outpatient Cervical Ripening and Labor Induction With Orally Administered Misoprostol for Term Pregnancies Complicated by Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00514618
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2006
- Primary completion
- Nov 30, 2008
- Completion
- Nov 30, 2008
- Last update posted
- Nov 6, 2023
2006 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00514618, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2023 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00514618 live on ClinicalTrials.gov.