Pregnancy Trimester, SecondPhase 4NCT00324519
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester
A Phase 4 study testing Foley bulb and misoprostol in people with Pregnancy Trimester, Second and Induced Abortion, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Trimester, Second, Induced Abortion
- What is being tested?
- Foley bulb and misoprostol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Apr 2007
- Phase
- Phase 4
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- indication for pregnancy termination, gestational age from 13-27 weeks
Who cannot join
- multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
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 two methods of pregnancy termination on the time to delivery in the second trimester.
Read the detailed description
Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.
- Conditions
- Pregnancy Trimester, Second, Induced Abortion
- Being tested
- Foley bulb, misoprostol
- Keywords
- second trimester, pregnancy termination, misoprostol, foley bulb
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley bulbDevice
misoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol Drug | Active comparator | This is the misoprostol drug. Receives: Drug: misoprostol |
| The Foley Bulb | Experimental | This is the experimental portion to test the Foley Bulb. Receives: Device: Foley bulb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to vaginal delivery
Secondary outcomes (3)
Rate of chorioamnionitis
Rate of maternal fever
Rate of postpartum hemorrhage
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 startFeb 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Trimester, SecondStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00324519
- Sponsor's protocol ID
- 12-2005
- Status last verified
- Mar 2012
- First submitted
- 10 May 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 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 Pregnancy Termination in the Second Trimester
- ClinicalTrials.gov ID
- NCT00324519
- Acronym / sponsor ID
- 12-2005
- Conditions
- Pregnancy Trimester, Second, Induced Abortion
- Keywords
- second trimester, pregnancy termination, misoprostol, foley bulb
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Apr 2007 (actual)
- 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 two methods of pregnancy termination on the time to delivery in the second trimester.
Detailed description
Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol Drug | Active comparator | Drug: misoprostolThis is the misoprostol drug. |
| The Foley Bulb | Experimental | Device: Foley bulbThis is the experimental portion to test the Foley Bulb. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- indication for pregnancy termination, gestational age from 13-27 weeks
Key exclusion criteria (1 listed)
- multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
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 |
|---|---|---|
| Foley bulb | Device | The Foley Bulb |
| misoprostol | Drug | Misoprostol Drug |
Primary outcome
Time to vaginal delivery
3 secondary outcomes
Rate of chorioamnionitis
Rate of maternal fever
Rate of postpartum hemorrhage
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 5 Mar 2012.
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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 4 study testing Foley bulb and misoprostol in people with Pregnancy Trimester, Second and Induced Abortion, 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 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 5 Mar 2012.