Cervical RipeningPhase 4NCT00886860
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
A Phase 4 study testing misoprostol in people with Cervical Ripening and Labor Induction, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol 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
- Cervical Ripening, Labor Induction
- What is being tested?
- misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- May 2009to Mar 2010
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 years old or more
- singleton pregnancy at 37 weeks gestation or more
- cephalic presentation
- reassuring fetal heart rate pattern
- admission for labor induction due to medical or obstetrical conditions
- bishop score less than 6
- giving consent and having signed the consent form for this study
Who cannot join
- parity more than 3
- estimated fetal weight more than 3,500 grams
- non-reassuring fetal heart rate pattern
- having contraindication for vaginal delivery
- previous uterine scar
- suspected abruptio placenta with non-reassuring fetal heart rate pattern
Show all 12Show fewer
- abnormal bleeding per vagina, except bloody show
- PROM
- having underlying cardiac, hepatic, or renal diseases
- having history of allergy to misoprostol or prostaglandin analogues
- cervical dilatation 3 centimeters or more
- uterine contraction 3 times or more in 10 minute
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol
- Conditions
- Cervical Ripening, Labor Induction
- Being tested
- misoprostol
- Keywords
- Efficacy, Cervical ripening/Labor induction, Titrated oral misoprostol/Conventional oral misoprostol, Term pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called cytotec
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
misoprostolDrug
Also called cytotec
misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
| Study group | Role | What they receive |
|---|---|---|
| conventional oral misoprostol | Active comparator | misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters Receives: Drug: misoprostol |
| titrated oral misoprostol | Experimental | misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of cervical ripening in labor induction
Measured: 12 hours after intervention
Secondary outcomes (1)
number of vaginal delivery
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 posted23 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionMar 2010
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 Cervical RipeningStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Kusol Russameecharoen, MD, Study director, Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886860
- Sponsor's protocol ID
- 091/2552(EC2)
- Status last verified
- Jul 2010
- First submitted
- 22 Apr 2009
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thaisomboon A, Russameecharoen K, Wanitpongpan P, Phattanachindakun B, Changnoi A. Comparison of the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction. Int J Gynaecol Obstet. 2012 Jan;116(1):13-6. doi: 10.1016/j.ijgo.2011.07.027. Epub 2011 Sep 28.
PubMed 21959071
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
- ClinicalTrials.gov ID
- NCT00886860
- Acronym / sponsor ID
- 091/2552(EC2)
- Conditions
- Cervical Ripening, Labor Induction
- Keywords
- Efficacy, Cervical ripening/Labor induction, Titrated oral misoprostol/Conventional oral misoprostol, Term pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Apr 2009 (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 efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional oral misoprostol | Active comparator | Drug: misoprostolmisoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters |
| titrated oral misoprostol | Experimental | Drug: misoprostolmisoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18 years old or more
- singleton pregnancy at 37 weeks gestation or more
- cephalic presentation
- reassuring fetal heart rate pattern
- admission for labor induction due to medical or obstetrical conditions
Key exclusion criteria (12 listed)
- parity more than 3
- estimated fetal weight more than 3,500 grams
- non-reassuring fetal heart rate pattern
- having contraindication for vaginal delivery
- previous uterine scar
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 |
|---|---|---|
| misoprostolAlso: cytotecmisoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm | Drug | conventional oral misoprostol |
| misoprostolAlso: cytotecmisoprostol 20 micrograms oral every hours until cervical dilatation 3 cm | Drug | titrated oral misoprostol |
Primary outcome
success rate of cervical ripening in labor induction
Time frame: 12 hours after intervention
1 secondary outcome
number of vaginal delivery
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 14 Jul 2010.
- Derived from this study: PubMed 21959071Thaisomboon A, Russameecharoen K, Wanitpongpan P, Phattanachindakun B, Changnoi A. Comparison of the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction. Int J Gynaecol Obstet. 2012 Jan;116(1):13-6. doi: 10.1016/j.ijgo.2011.07.027. Epub 2011 Sep 28.
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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.
Kusol Russameecharoen, MD study director
Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
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 misoprostol in people with Cervical Ripening and Labor Induction, run by Mahidol University at 1 site in Thailand.
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 7 inclusion and 12 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 14 Jul 2010. 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 Thailand. 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?
success rate of cervical ripening in labor induction (time frame: 12 hours after intervention). 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 NCT00886860, 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 14 Jul 2010.