Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by China Medical University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
China Medical University Hospital
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00695331
First received: June 8, 2008
Last updated: July 8, 2008
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Labor |
Drug: Misoprostol Drug: Oxytocin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by China Medical University Hospital:
Primary Outcome Measures:
- the percentage of women delivering infants vaginally within 12 hours of augmentation [ Time Frame: post vaginal delivery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- uterine hyperstimulation rate [ Time Frame: post vaginal delivery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 143 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Titrated Oral Misoprostol Solution
|
Drug: Misoprostol
Titrated Misoprostol Solution
Other Name: Cytotec
|
|
Active Comparator: 2
Intravenous Oxytocin
|
Drug: Oxytocin
Titrated Intravenous Oxytocin
Other Name: Piton-S
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695331
Contacts
| Contact: Ming Ho, MD | 886-4-22062121 ext 4132 | mi.ho@msa.hinet.net |
| Contact: Shi-Yann Cheng, MD | 886-5-7837901 ext 1502 | shiyann@ms18.url.com.tw |
Locations
| Taiwan | |
| Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital | Recruiting |
| Taichung, Taiwan, 404 | |
| Contact: Ming Ho, MD 886-4-22062121 ext 4132 mi.ho@msa.hinet.net | |
| Contact: Shi-Yann Cheng, MD 886-5-7837901 ext 1502 shiyann@ms18.url.com.tw | |
| Principal Investigator: Ming Ho, MD | |
Sponsors and Collaborators
China Medical University Hospital
Investigators
| Study Chair: | Shi-Yann Cheng, MD | China Medical University Beigang Hospital |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shi-Yann Cheng, China Medical University Beigang Hospital |
| ClinicalTrials.gov Identifier: | NCT00695331 History of Changes |
| Other Study ID Numbers: | CMUBH R96007, DMR96-IRB-176 |
| Study First Received: | June 8, 2008 |
| Last Updated: | July 8, 2008 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by China Medical University Hospital:
|
Labor Augmentation Misoprostol Oxytocin |
Additional relevant MeSH terms:
|
Oxytocin Misoprostol Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013