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Trial record 8 of 9083 for:    pregnancy

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

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ClinicalTrials.gov Identifier: NCT02299401
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Misoprostol Device: Semi-quantitative pregnancy test Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: SQPT

Experimental: 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.
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.
Other Name: SQPT




Primary Outcome Measures :
  1. Ongoing pregnancy rates [ Time Frame: 1-2 weeks ]
    The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up.


Secondary Outcome Measures :
  1. Incidence of side effects and complications as a measure of safety/ side effects [ Time Frame: 1-2 weeks ]
    Assess and compare the safety/side effects of two regimens of misoprostol alone for early pregnancy termination.

  2. Reported acceptability and satisfaction with misoprostol regimen [ Time Frame: 1-2 weeks ]
    The study will also assess and compare satisfaction and acceptability of each medical abortion regimen as rated by the women.

  3. Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home [ Time Frame: 1-2 weeks ]
    The study will assess women's ability to use the SQPT effectively for at-home assessment of the success of the medical abortion procedure.

  4. Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up [ Time Frame: 1-2 weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299401


Locations
Bolivia
Reproductive Health Clinic
La Paz, Pedro Domingo Murillo, Bolivia
Ecuador
Reproductive Health Clinic
Quito, Ecuador
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Study Director: Wendy R Sheldon, PhD Gynuity Health Projects

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02299401     History of Changes
Other Study ID Numbers: 6006
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Gynuity Health Projects:
Medical abortion
Induced abortion
Pregnancy test
Semi-quantitative pregnancy test

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics