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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299401
• Other study ID #: 6006
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 13, 2014
• Last updated: November 2, 2016
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Misoprostol
Women will receive three 800 mcg doses of misoprostol.

Device:
• Semi-quantitative pregnancy test
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.

Locations

Country	Name	City	State
Bolivia	Reproductive Health Clinic	La Paz	Pedro Domingo Murillo
Ecuador	Reproductive Health Clinic	Quito

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Bolivia,  Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No