Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Misoprostol | Active Comparator | 400 mcg of sublingual misoprostol |
|
| Oral Misoprostol | Active Comparator | Misoprostol administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone, misoprostol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. | 2 weeks after mifepristone administration |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | 48 hours | |
| Acceptability for women | 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sheila Raghavan, M.Sc. | Gynuity Health Projects | Study Director |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Rasha Dabash, MPH | Gynuity Health Projects | Study Director |
| Selma Hajri, MD | Reproductive Health Consultant | Principal Investigator |
| Ayse Akin, MD, MPH | Baskent University | Principal Investigator |
| Ilana Dzuba, MHS | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of Medicine and Pharmacy | Chisinau | Moldova | ||||
| Centre de Planification Familiale de l'Ariana |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aryanah |
| Tunisia |
| Centre de Planification Familiale la Bardo | Tunis | Tunisia |
| Maternité de La Rabta | Tunis | Tunisia |
| Private clinic | Tunis | Tunisia |
| Dr. Zekai Tahir Burak Women's Health Training and Research Hospital | Ankara | Turkey (Türkiye) |
| MoH Ankara Etlik Maternity and Gyneacological Training Hospital | Ankara | Turkey (Türkiye) |
| Haydarpaşa Numune Training and Research Hospital Family Planning Clinic | Istanbul | Turkey (Türkiye) |
| Ege Maternity and Gyneacological Training and Research Hospital | Izmir | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| 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 |
Not provided
Not provided