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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Medical Abortion

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64-84 days gestational age<br>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<br>* Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.<br>Drug: Misoprostol<br>* 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.<br>|
| No Intervention: 57-63 days gestational age<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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 |  | 2-4 weeks | 
| Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group |  | 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 |  | 2-4 weeks | 
| Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group |  | 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 |  | 2-4 weeks | 
| Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group |  | 2-4 weeks | 
| Number of participants requiring an unscheduled clinic visit, by gestational age group |  | 2-4 weeks | 
| Number of participants who called the helpline, by gestational age group |  | 2-4 weeks | 
| Time to expulsion in days, by gestational age group |  | 2-4 weeks | 
| Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group |  | 2-4 weeks | 
| Duration of heavy bleeding, by gestational age group |  | 2-4 weeks | 
| Duration of work or school missed, by gestational age group |  | 2-4 weeks | 
| Pain reliever use |  | 2-4 weeks | 
| Satisfied or very satisfied with abortion method, by gestational age group |  | 2-4 weeks | 
| Would choose medical abortion again instead of surgical, by gestational age group |  | 2-4 weeks | 
| Would recommend abortion method to a friend, by gestational age group |  | 2-4 weeks | 
| Proportion of participants who saw products of pregnancy, by gestational age group |  | 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 |  | 2-4 weeks | 
| Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention |  | 2-4 weeks | 
| Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention |  | 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 |  | 2-4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion induced, Patient Acceptance of Healthcare, safety, effectiveness, misoprostol, mifepristone