Labor Induction at TermNCT01070472
Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
A study testing Misoprostol in people with Labor Induction at Term, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Labor Induction at Term
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Jun 2011
- Phase
- Interventional
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- term,
- singleton
- no contraindication to prostaglandins
- vertex
- no exposure to vaginal prostaglandins in the index pregnancy
Who cannot join
- parity > 3
- severe PIH: BP> 160/100, abnormal LFT's, proteinuria >1g/day
- previous uterine surgery
- regular uterine contractions
- maternal age > 45
- twins
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.
- Conditions
- Labor Induction at Term
- Being tested
- Misoprostol
- Keywords
- labor induction at term using a titrated oral misoprostol solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
titrated oral misoprostol solution
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of vaginal delivery within 24 hours
Measured: 24 hours
Secondary outcomes (1)
Uterine hyperstimulation rate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Induction at TermStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. debbie Robinson, University of Manitoba
- Investigators
- debbie J Robinson, MD FRCSC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070472
- Sponsor's protocol ID
- B2009:149
- Status last verified
- Dec 2013
- First submitted
- 16 Feb 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
- ClinicalTrials.gov ID
- NCT01070472
- Acronym / sponsor ID
- B2009:149
- Conditions
- Labor Induction at Term
- Keywords
- labor induction at term using a titrated oral misoprostol solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Feb 2010 (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 determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- term,
- singleton
- no contraindication to prostaglandins
- vertex
- no exposure to vaginal prostaglandins in the index pregnancy
Key exclusion criteria (6 listed)
- parity > 3
- severe PIH: BP> 160/100, abnormal LFT's, proteinuria >1g/day
- previous uterine surgery
- regular uterine contractions
- maternal age > 45
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 |
|---|---|---|
| Misoprostoltitrated oral misoprostol solution | Drug | – |
Primary outcome
Rate of vaginal delivery within 24 hours
Time frame: 24 hours
1 secondary outcome
Uterine hyperstimulation rate
Time frame: 24 hours
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 10 Dec 2013.
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Induction of Labor
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.
debbie J Robinson, MD FRCSC principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Labor Induction at Term, run by University of Manitoba at 1 site in Canada.
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 5 inclusion and 6 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 10 Dec 2013. 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 Canada. 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.
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?
Rate of vaginal delivery within 24 hours (time frame: 24 hours). 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 10 Dec 2013.