Medical; Abortion, Fetus Clinical Trial
Official title:
Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation
The purpose of this study is to determine the efficacy and acceptability of a regimen of 200 mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.
In Mexico City, the registration of a new mifepristone product signals a new wave in the
SSDF's program for terminating pregnancies up to 70 days. This study evaluates the efficacy
of the product Zacafemyl for the termination of pregnancy up to 70 days LMP. It also
evaluates the incidence and acceptability of side effects of the medication and regimen.
Participants are women of reproductive age with a gestational age of less than or equal to
70 days who want and are eligible for medical abortion, are willing and able to provide all
follow up information, and have no contraindications.
Women who are eligible and consent to enroll in the study will be given 200 mg of
mifepristone orally in the clinic. The participants will then be given 800 mcg of
misoprostol (four 200 mcg tablets) to take home and instructed to take two tablets bucally
24-48 hours after the mifepristone and the remaining tablets within 30 minutes. They will be
warned of the side effects they may experience.
All participants will be informed that they can call the clinic in case they have questions
about the symptoms or side effects or if they have other concerns. They will also be told
that they can return to the clinic in case of severe or persistent bleeding, or if they
decide at any point that they want surgical intervention. Participants will also be informed
as to the signs of pregnancy termination.
Seven days after taking the mifepristone (the eighth day of the study) the woman should
return to the clinic for follow up. Information will be collected on a series of six
semi-structured forms that are filled out by members of the study team in accordance with
the responses of the participants to the interview questions and the results of physical
exams, ultrasounds, etc. Analyses of the data will focus on efficacy, acceptability, side
effects, and adverse events.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02694198 -
Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion
|
N/A | |
| Completed |
NCT01860521 -
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
|
N/A | |
| Withdrawn |
NCT04304365 -
Home Follow-up After Medication Abortion
|
N/A | |
| Completed |
NCT03400358 -
Uterocervical Angle in the Pregnancy Termination of Multiparous Women
|
N/A | |
| Recruiting |
NCT05342467 -
Gemeprost Versus Dinoprostone in First Trimester Miscarriages
|
Phase 2 | |
| Recruiting |
NCT03269279 -
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
|
Phase 3 | |
| Completed |
NCT02381223 -
Simplified Medical Abortion Screening: A Pilot Demonstration Project
|
N/A | |
| Recruiting |
NCT05940233 -
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
|
N/A | |
| Not yet recruiting |
NCT03570307 -
Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage First-trimester Miscarriage
|
N/A | |
| Completed |
NCT01943279 -
Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion
|
N/A | |
| Not yet recruiting |
NCT04194658 -
Effectiveness of Pretreatment Letrozole Versus Misoprostol Alone in Missed Abortion
|
Phase 2 | |
| Completed |
NCT03194126 -
Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination
|
N/A |