Labor, InducedPhase 2NCT00393731
A Randomized, Control Trial for Preinduction Cervical Ripening
A Phase 2 study testing Misoprostol and oxytocin in people with Labor, Induced, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Misoprostol and oxytocin
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Aug 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- Women that are hospitalized for induction of labor that have a Bishop's score <5
- singleton gestation
- cephalic presentation
- 24 weeks gestational age
Who cannot join
- Prior uterine surgery
- malpresentation
- placenta previa or abruption
- clinically suspected or diagnosed intra amniotic infection
- genital HSV infection
- multiple gestation
Show all 9Show fewer
- premature rupture of the membranes
- active labor
- maternal/fetal conditions that may preclude labor induction in the opinion of the investigators
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.
- Conditions
- Labor, Induced
- Being tested
- Misoprostol, oxytocin
- Keywords
- labor, induction, misoprostol, oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
oxytocinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Delivery rates
Secondary outcomes (1)
Time interval to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startJan 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Investigators
- Michael Lucas, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393731
- Sponsor's protocol ID
- HSC-MS-04-008
- Status last verified
- Jan 2008
- First submitted
- 26 Oct 2006
- Last updated
- 16 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Control Trial for Preinduction Cervical Ripening
- ClinicalTrials.gov ID
- NCT00393731
- Acronym / sponsor ID
- HSC-MS-04-008
- Conditions
- Labor, Induced
- Keywords
- labor, induction, misoprostol, oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Oct 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 goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women that are hospitalized for induction of labor that have a Bishop's score <5
- singleton gestation
- cephalic presentation
- 24 weeks gestational age
Key exclusion criteria (9 listed)
- Prior uterine surgery
- malpresentation
- placenta previa or abruption
- clinically suspected or diagnosed intra amniotic infection
- genital HSV infection
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 | – |
| oxytocin | Drug | – |
Primary outcome
Vaginal Delivery rates
1 secondary outcome
Time interval to delivery
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 16 Jan 2008.
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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.
Michael Lucas, MD principal investigator
The University of Texas Health Science Center, Houston
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 oxytocin in people with Labor, Induced, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 9 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 16 Jan 2008. 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?
Vaginal Delivery rates. 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 16 Jan 2008.