Premature BirthPhase 2NCT00325026
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
A Phase 2 study testing Misoprostol and Foley bulb in people with Premature Birth and Cervical Ripening, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Cervical Ripening
- What is being tested?
- Misoprostol and Foley bulb
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton gestation, gestational age 23-35 weeks, indication for induction
Who cannot join
- multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
About this study
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.
Read the detailed description
Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.
- Conditions
- Premature Birth, Cervical Ripening
- Being tested
- Misoprostol, Foley bulb
- Keywords
- Preterm gestation, Cervical ripening, Labor induction, Misoprostol, Foley bulb
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Foley bulbDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to vaginal delivery
Secondary outcomes (4)
Rate of chorioamnionitis
Incidence of abnormal fetal heart rate tracings
Rate of postpartum hemorrhage
Incidence of NICU admissions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startApr 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keri a Baacke, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325026
- Sponsor's protocol ID
- 594-2004
- Status last verified
- Mar 2012
- First submitted
- 10 May 2006
- Last updated
- 2 Mar 2012
- Results posted
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
- ClinicalTrials.gov ID
- NCT00325026
- Acronym / sponsor ID
- 594-2004
- Conditions
- Premature Birth, Cervical Ripening
- Keywords
- Preterm gestation, Cervical ripening, Labor induction, Misoprostol, Foley bulb
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.
Detailed description
Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- singleton gestation, gestational age 23-35 weeks, indication for induction
Key exclusion criteria (1 listed)
- multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol | Drug | – |
| Foley bulb | Device | – |
Primary outcome
Time to vaginal delivery
4 secondary outcomes
Rate of chorioamnionitis
Incidence of abnormal fetal heart rate tracings
Rate of postpartum hemorrhage
Incidence of NICU admissions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keri a Baacke, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol and Foley bulb in people with Premature Birth and Cervical Ripening, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to vaginal delivery. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.