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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014