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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone at home 24 hours before miso dosing starts | Experimental | 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. |
|
| Mifepristone and first dose of misoprostol simultaneously. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | 200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol |
|
| 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. | Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention. | Within 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Induction to abortion interval | Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta. | Within 1 week |
| Women's acceptability of the assigned method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Binh duong Obstetrics and Newborn Hospital | Ho Chi Minh City | Binh Duong Province | Vietnam | |||
| National Ob-Gyn Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741182 | Derived | Abbas DF, Blum J, Ngoc NT, Nga NT, Chi HT, Martin R, Winikoff B. Simultaneous Administration Compared With a 24-Hour Mifepristone-Misoprostol Interval in Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1077-1083. doi: 10.1097/AOG.0000000000001688. |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Misoprostol | Drug | 200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol |
|
| Within 1 week |
| Rate of fetal expulsion | Defined as fetal expulsion with study drug alone. | Within 1 week |
| Provision of additional interventions | For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs | Within 1 week |
| Time interval from the mifepristone dose to abortion | Defined as length of time from initiation of mifepristone to complete abortion achieved. | Within 1 week |
| Total dose of misoprostol administered | Within 1 week |
| Hanoi |
| Vietnam |
| Hung Vuong Hospital | Ho Chi Minh City | Vietnam |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |