Clinical trial NCT02299401: Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up
Official title: Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pregnancy
Keywords: Medical abortion
Induced abortion
Pregnancy test
Semi-quantitative pregnancy test
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 401
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.


Eligibility criteria: Inclusion Criteria:

* Presents for voluntary termination of pregnancy
* Gestational age ≤ 70 days by last menstrual period plus clinical assessment or ultrasound
* General good health including the absence of conditions which contraindicate the use of misoprostol for pregnancy termination
* Agrees to return for follow-up visit and willing to provide an address and/or telephone number for the purposes of follow-up
* Able to consent to study participation

Exclusion Criteria:

* Gestational age \> 70 days last menstrual period
* Confirmed or suspected ectopic or molar pregnancy
* Contraindications to medical abortion include having an intrauterine device in place and history of allergy to misoprostol or other prostaglandins

Primary outcomes:
measure: Ongoing pregnancy rates
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Incidence of side effects and complications as a measure of safety/ side effects
timeFrame: 1-2 weeks
measure: Reported acceptability and satisfaction with misoprostol regimen
timeFrame: 1-2 weeks
measure: Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home
timeFrame: 1-2 weeks
measure: Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: La Paz
country: Bolivia
facility: Reproductive Health Clinic
state: Pedro Domingo Murillo
city: Quito
country: Ecuador
facility: Reproductive Health Clinic
Study officials:
affiliation: Gynuity Health Projects
name: Wendy R Sheldon, PhD
role: STUDY_DIRECTOR
References:
citation: Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1.