Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks

June 16, 2016 updated by: Ibis Reproductive Health

The Effectiveness, Safety, and Acceptability of Home-administered Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks: A Prospective Cohort Study in Mexico City

The purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12 weeks among a cohort of women in Mexico City.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Medical abortion represents an important alternative to surgical methods for termination of early pregnancy. In Mexico City, abortion is legal on request up to 12 weeks of gestation; however, medical abortion is currently only offered up to 10 weeks at Marie Stopes Mexico clinics. The World Health Organization guidelines state that medical abortion drugs may be used to terminate pregnancy up to a gestational age of 24 weeks in clinical settings, with recommended regimens differing by gestational age. However, data are lacking on the safety and effectiveness of home-based medical abortion regimens for pregnancy terminations between >9 and ≤12 weeks' gestation. Investigators propose a prospective cohort study with women between 8 and ≤9 weeks and >9 and ≤12 weeks of pregnancy at Marie Stopes Mexico clinics to compare the effectiveness, safety, and acceptability of mifepristone followed by home-based misoprostol use in these two gestational age groups. The information from this study will inform policy and practice guidelines in Mexico City and potentially other locations by providing evidence on the safety, effectiveness, and acceptability of home-use of medical abortion between >9 and ≤12 weeks of gestation.

Study Type

Interventional

Enrollment (Anticipated)

648

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Mexico Distrito Federal
      • Del. Azcapotzalco, Mexico Distrito Federal, Mexico, 02000
        • Marie Stopes Mexico Azcapotzalco
      • Del. Cuauhtémoc, Mexico Distrito Federal, Mexico, 06760
        • Marie Stopes Mexico Roma
      • Del. Tlalpan, Mexico Distrito Federal, Mexico, 14010
        • Marie Stopes Mexico Pedregal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged 18 or older
  • Intrauterine pregnancy 57- 84 days, assessed using clinical assessment and transvaginal or transabdominal ultrasound by crown-rump length (machines will be calibrated and will use a standardized conversion formula to determine gestational age)
  • Eligible for medical abortion according to doctor assessment
  • Elected medical abortion over surgical abortion after comprehensive counselling
  • Haemoglobin level ≥10 g/dl measured by Hemocue
  • Willing and able to sign consent forms
  • Able to speak and read Spanish
  • Agree to comply with the study procedures and visit schedule
  • Access to own telephone and to emergency transportation
  • Access to a toilet with privacy
  • Reside no more than 30 minutes car journey from the Sta. Mónica Hospital in Polanco or the Marie Stopes Mexico Roma Clinic

Exclusion Criteria:

  • History or evidence of disorders that represent a contraindication to the use of mifepristone or misoprostol (chronic adrenal failure, severe asthma uncontrolled by corticosteroid therapy, inherited porphyries, glaucoma, mitral stenosis, hepatic or renal disease)
  • History of bleeding disorder or current anticoagulant therapy
  • Previous allergic reaction to any drugs in the regimen
  • Suspicion of any pathology of pregnancy (e.g. molar, ectopic, non-viable pregnancy)
  • Multiple gestation
  • Presence of an intrauterine device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 64-84 days gestational age
Women whose pregnancies are estimated to have a gestational age of 64-84 days will receive 200 µg mifepristone followed by misoprostol 24-48 hours later.
Drug: Mifepristone
Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.
Drug: Misoprostol
The client will then be given a total of 2400 µg misoprostol tablets to take home, and will be instructed to take 800 μg misoprostol administered sublingually 24-48 hours later at home and to administer a subsequent dose of 400 μg misoprostol sublingually every 3 hours up to a total of four further doses or until expulsion of the products of conception, whichever comes first.
No Intervention: 57-63 days gestational age
Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range: 200 µg mifepristone administered orally in the clinic on Day 1 then 800 μg misoprostol administered sublingually 24-48 hours later at home with a subsequent dose of 400 μg misoprostol sublingually 6 hours later if she has not expelled the pregnancy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with complete abortion without surgical intervention by day 30 from mifepristone administration, regardless of misoprostol dosing, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Experience of any major adverse event overall, and by type (emergency room treatment, hospitalization, transfusion, unrecognized ectopic pregnancy, allergic reaction, infection requiring intravenous treatment, and death), by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Proportion of participants by gestational age group with complete abortion without surgical intervention after 1, 2, 3, 4, and 5 doses of misoprostol, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to the presence of a persistent non-viable sac, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to excessive prolonged bleeding indicated as severe on the adverse event form, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants requiring an unscheduled clinic visit, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Number of participants who called the helpline, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Time to expulsion in days, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Duration of heavy bleeding, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Duration of work or school missed, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Pain reliever use
Time Frame: 2-4 weeks
2-4 weeks
Satisfied or very satisfied with abortion method, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Would choose medical abortion again instead of surgical, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Would recommend abortion method to a friend, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Proportion of participants who saw products of pregnancy, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks
Proportion of participants who saw products of pregnancy who reported feelings as: nothing/no feeling, relieved, sad, uncomfortable, other, by gestational group
Time Frame: 2-4 weeks
2-4 weeks
Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention
Time Frame: 2-4 weeks
2-4 weeks
Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention
Time Frame: 2-4 weeks
2-4 weeks
Did not receive a contraceptive method by follow-up visit, but don't want to get pregnant in next 12 months, by gestational age group
Time Frame: 2-4 weeks
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibis Reproductive Health

Collaborators

Marie Stopes International

Investigators

  • Principal Investigator: Daniel Grossman, MD, Ibis Reproductive Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSI-6103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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