LaborPhase 4NCT00695331
Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation
A Phase 4 study testing Misoprostol and Oxytocin in people with Labor, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to Jan 2009
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy between 36 and 42 weeks of gestation
- Live singleton
- Cephalic presentation
- A reassuring fetal heart rate pattern
- Bishop score greater than 6
- Inadequate uterine contraction (less than or equal to 2 per 10 minutes)
Who cannot join
- Nonreassuring fetal heart rate pattern
- Parity more than five
- Uterine scar
- Suspected placental abruption with abnormal fetal heart rate
- Vaginal bleeding other than "bloody show"
- Significant maternal cardiac, renal, or hepatic disease
- hypersensitivity to oxytocin, misoprostol or prostaglandin analogues
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital
Taichung, 404
Ming Ho, MD, 886-4-22062121 ext. 4132, mi.ho@msa.hinet.net
Shi-Yann Cheng, MD, 886-5-7837901 ext. 1502, shiyann@ms18.url.com.tw
About this study
Official title: A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.
Read the detailed description
Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.
In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.
- Conditions
- Labor
- Being tested
- Misoprostol, Oxytocin
- Keywords
- Labor Augmentation, Misoprostol, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Titrated Misoprostol Solution
OxytocinDrug
Also called Piton-S
Titrated Intravenous Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Titrated Oral Misoprostol Solution Receives: Drug: Misoprostol |
| 2 | Active comparator | Intravenous Oxytocin Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of women delivering infants vaginally within 12 hours of augmentation
Measured: post vaginal delivery
Secondary outcomes (1)
uterine hyperstimulation rate
Measured: post vaginal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shi-Yann Cheng, MD, Study chair, China Medical University Beigang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695331
- Sponsor's protocol ID
- CMUBH R96007
- Other IDs
- DMR96-IRB-176
- Status last verified
- Jul 2008
- First submitted
- 8 Jun 2008
- Last updated
- 10 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71.
PubMed 18165400Ho M, Cheng SY, Li TC. Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.
PubMed 20733443
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00695331
- Acronym / sponsor ID
- CMUBH R96007
- Conditions
- Labor
- Keywords
- Labor Augmentation, Misoprostol, Oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 11 Jun 2008 (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 and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.
Detailed description
Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.
In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MisoprostolTitrated Oral Misoprostol Solution |
| 2 | Active comparator | Drug: OxytocinIntravenous Oxytocin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnancy between 36 and 42 weeks of gestation
- Live singleton
- Cephalic presentation
- A reassuring fetal heart rate pattern
- Bishop score greater than 6
Key exclusion criteria (7 listed)
- Nonreassuring fetal heart rate pattern
- Parity more than five
- Uterine scar
- Suspected placental abruption with abnormal fetal heart rate
- Vaginal bleeding other than "bloody show"
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: CytotecTitrated Misoprostol Solution | Drug | 1 |
| OxytocinAlso: Piton-STitrated Intravenous Oxytocin | Drug | 2 |
Primary outcome
the percentage of women delivering infants vaginally within 12 hours of augmentation
Time frame: post vaginal delivery
1 secondary outcome
uterine hyperstimulation rate
Time frame: post vaginal delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2008.
- Background: PubMed 18165400Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71.
- Derived from this study: PubMed 20733443Ho M, Cheng SY, Li TC. Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.
- China Medical University HospitalLink provided by the sponsor.
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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.
Shi-Yann Cheng, MD study chair
China Medical University Beigang Hospital
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 and Oxytocin in people with Labor, run by China Medical University Hospital at 1 site in Taiwan.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jul 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Ho, MD (886-4-22062121 ext. 4132, mi.ho@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of women delivering infants vaginally within 12 hours of augmentation (time frame: post 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 NCT00695331, which also lists 2 linked publications.
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 Jul 2008.