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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: Clinical Trial NA study, sponsored by MemorialCare Health System.

NCT00514618 is a NA study that was terminated before completion, run by MemorialCare Health System. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DRUG Misoprostol

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2006-03
Est. Completion 2008-12
Phase NA
MemorialCare Health System

21 total trials

Why NCT00514618 stopped before completion

NCT00514618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00514618 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00514618's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00514618, the US trial registry maintained by the National Library of Medicine. NCT00514618 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.