Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)
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Purpose
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
| Condition | Intervention | Phase |
|---|---|---|
|
Complete Uterine Evacuation After Use of Study Drugs |
Drug: Mifepristone Drug: Misoprostol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial |
- 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 ] [ Designated as safety issue: No ]Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
- Induction to abortion interval [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.
- Women's acceptability of the assigned method. [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
- Rate of fetal expulsion [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]Defined as fetal expulsion with study drug alone.
- Provision of additional interventions [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs
- Time interval from the mifepristone dose to abortion [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]Defined as length of time from initiation of mifepristone to complete abortion achieved.
- Total dose of misoprostol administered [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 504 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Drug: Mifepristone
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. |
Drug: Misoprostol
200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Nhu thi Nguyen Ngoc, MD | nhungoccrcrh@gmail.com |
| Vietnam | |
| National Ob-Gyn Hospital | Not yet recruiting |
| Hanoi, Vietnam | |
| Contact: Nguyen thi Hong Minh, MD | |
| Sub-Investigator: Nguyen thi Hong Minh, MD | |
| Hung Vuong Hospital | Recruiting |
| Ho Chi Minh City, Vietnam | |
| Contact: Nguyen Thi Bach Nga, MD | |
| Principal Investigator: Nguyễn thị Bạch Nga, Nga | |
| Principal Investigator: | Jennifer Blum, MPH | Gynuity Health Projects |
| Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects |
| Principal Investigator: | Dina Abbas, MPH | Gynuity Health Projects |
| Principal Investigator: | Nguyen thi Ngoc, MD | Hung Vuong Hospital |
More Information
No publications provided
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT01768299 History of Changes |
| Other Study ID Numbers: | 1008 |
| Study First Received: | January 11, 2013 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Vietnam: Scientific Committee, Hung Vuong Hospital Additional IRB: National Hospital OB-GYN, Hanoi, Vietnam |
Keywords provided by Gynuity Health Projects:
|
abortion medical abortion mifepristone misoprostol |
Additional relevant MeSH terms:
|
Mifepristone Misoprostol Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic |
Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on June 17, 2013