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Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695331
Recruitment Status : Unknown
Verified July 2008 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : June 11, 2008
Last Update Posted : July 10, 2008
Information provided by:
China Medical University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Labor Drug: Misoprostol Drug: Oxytocin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
Study Start Date : February 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. the percentage of women delivering infants vaginally within 12 hours of augmentation [ Time Frame: post vaginal delivery ]

Secondary Outcome Measures :
  1. uterine hyperstimulation rate [ Time Frame: post vaginal delivery ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695331

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Contact: Ming Ho, MD 886-4-22062121 ext 4132
Contact: Shi-Yann Cheng, MD 886-5-7837901 ext 1502

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Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital Recruiting
Taichung, Taiwan, 404
Contact: Ming Ho, MD    886-4-22062121 ext 4132   
Contact: Shi-Yann Cheng, MD    886-5-7837901 ext 1502   
Principal Investigator: Ming Ho, MD         
Sponsors and Collaborators
China Medical University Hospital
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Study Chair: Shi-Yann Cheng, MD China Medical University Beigang Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shi-Yann Cheng, China Medical University Beigang Hospital Identifier: NCT00695331    
Other Study ID Numbers: CMUBH R96007
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: July 10, 2008
Last Verified: July 2008
Keywords provided by China Medical University Hospital:
Labor Augmentation
Additional relevant MeSH terms:
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Pharmaceutical Solutions
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents