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NCT00514618 · ClinicalTrials.gov registry record · NA
Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics
A NA study, sponsored by MemorialCare Health System.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT00514618 is a NA study that was terminated before completion, run by MemorialCare Health System. The registered enrollment target is 5 participants.
The verdict
NCT00514618, a NA study, was terminated before completion, sponsored by MemorialCare Health System.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DRUG Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00514618
The ClinicalTrials.gov registry entry for NCT00514618 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MemorialCare Health System, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00514618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00514618 about?
NCT00514618 is a clinical study titled "Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics". 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....
What is the current status of trial NCT00514618?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2006-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00514618?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Misoprostol (DRUG).
Who is sponsoring clinical trial NCT00514618?
This trial is sponsored by MemorialCare Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
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