- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768299
Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)
Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Hanoi, Vietnam
- National Ob-Gyn Hospital
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Ho Chi Minh City, Vietnam
- Hung Vuong Hospital
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Binh Duong Province
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Ho Chi Minh City, Binh Duong Province, Vietnam
- Binh duong Obstetrics and Newborn Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- No contraindications to medical abortion and study procedures, according to provider
- Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
- Willing to follow study procedures
Exclusion Criteria:
- Known previous transmural uterine incision
- > 5 parity
- Signs and symptoms of infection
- Any contraindications to vaginal delivery, including placenta previa
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mifepristone at home 24 hours before miso dosing starts
All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. |
200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
|
EXPERIMENTAL: Mifepristone and first dose of misoprostol simultaneously.
Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled. |
200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
Time Frame: Within 1 week
|
Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
|
Within 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Induction to abortion interval
Time Frame: Within 1 week
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Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.
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Within 1 week
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Women's acceptability of the assigned method.
Time Frame: Within 1 week
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Within 1 week
|
|
Rate of fetal expulsion
Time Frame: Within 1 week
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Defined as fetal expulsion with study drug alone.
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Within 1 week
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Provision of additional interventions
Time Frame: Within 1 week
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For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs
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Within 1 week
|
Time interval from the mifepristone dose to abortion
Time Frame: Within 1 week
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Defined as length of time from initiation of mifepristone to complete abortion achieved.
|
Within 1 week
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Total dose of misoprostol administered
Time Frame: Within 1 week
|
Within 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nguyen thi Ngoc, MD, Hung Vuong Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Anti-Ulcer Agents
- Contraceptives, Oral, Synthetic
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Luteolytic Agents
- Abortifacient Agents, Steroidal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Menstruation-Inducing Agents
- Misoprostol
- Mifepristone
Other Study ID Numbers
- 1008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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