Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up
NCT ID: NCT02299401
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
401 participants
INTERVENTIONAL
2014-12-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Buccal
Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
Misoprostol
Women will receive three 800 mcg doses of misoprostol.
Semi-quantitative pregnancy test
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
Sublingual
Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
Misoprostol
Women will receive three 800 mcg doses of misoprostol.
Semi-quantitative pregnancy test
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
Interventions
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Misoprostol
Women will receive three 800 mcg doses of misoprostol.
Semi-quantitative pregnancy test
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Wendy R Sheldon, PhD
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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Reproductive Health Clinic
La Paz, Pedro Domingo Murillo, Bolivia
Reproductive Health Clinic
Quito, , Ecuador
Countries
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References
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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.
Other Identifiers
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6006
Identifier Type: -
Identifier Source: org_study_id