Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Misoprostol
* Device: Semi-quantitative pregnancy test


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buccal<br>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. | Drug: Misoprostol<br>* Women will receive three 800 mcg doses of misoprostol.<br>Device: Semi-quantitative pregnancy test<br>* All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.<br>* Other names: SQPT;|
| Experimental: Sublingual<br>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. | Drug: Misoprostol<br>* Women will receive three 800 mcg doses of misoprostol.<br>Device: Semi-quantitative pregnancy test<br>* All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.<br>* Other names: SQPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rates | The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up. | 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effects and complications as a measure of safety/ side effects | Assess and compare the safety/side effects of two regimens of misoprostol alone for early pregnancy termination. | 1-2 weeks | 
| Reported acceptability and satisfaction with misoprostol regimen | The study will also assess and compare satisfaction and acceptability of each medical abortion regimen as rated by the women. | 1-2 weeks | 
| Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home | The study will assess women's ability to use the SQPT effectively for at-home assessment of the success of the medical abortion procedure. | 1-2 weeks | 
| Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up | The study will also assess the acceptability of the test as a means for at-home follow-up after medical abortion as rated by the women. The woman will answer questions about whether she found the SQPT easy to use an acceptable for at-home follow up. | 1-2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical abortion, Induced abortion, Pregnancy test, Semi-quantitative pregnancy test