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

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ClinicalTrials.gov Identifier: NCT02745093
Recruitment Status : Unknown
Verified June 2016 by Ibis Reproductive Health.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
Marie Stopes International
Information provided by (Responsible Party):
Ibis Reproductive Health

Tracking Information
First Submitted Date  ICMJE August 7, 2015
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date June 20, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • 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 ]
  • 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 ]
  • Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group [ Time Frame: 2-4 weeks ]
  • Number of participants requiring an unscheduled clinic visit, by gestational age group [ Time Frame: 2-4 weeks ]
  • Number of participants who called the helpline, by gestational age group [ Time Frame: 2-4 weeks ]
  • Time to expulsion in days, by gestational age group [ Time Frame: 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 ]
  • Duration of heavy bleeding, by gestational age group [ Time Frame: 2-4 weeks ]
  • Duration of work or school missed, by gestational age group [ Time Frame: 2-4 weeks ]
  • Pain reliever use [ Time Frame: 2-4 weeks ]
  • Satisfied or very satisfied with abortion method, by gestational age group [ Time Frame: 2-4 weeks ]
  • Would choose medical abortion again instead of surgical, by gestational age group [ Time Frame: 2-4 weeks ]
  • Would recommend abortion method to a friend, by gestational age group [ Time Frame: 2-4 weeks ]
  • Proportion of participants who saw products of pregnancy, by gestational age group [ Time Frame: 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 ]
  • Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention [ Time Frame: 2-4 weeks ]
  • Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks
Official Title  ICMJE 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
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Medical Abortion
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Mifepristone
    • Drug: Misoprostol
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
648
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02745093
Other Study ID Numbers  ICMJE MSI-6103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ibis Reproductive Health
Study Sponsor  ICMJE Ibis Reproductive Health
Collaborators  ICMJE Marie Stopes International
Investigators  ICMJE
Principal Investigator: Daniel Grossman, MD Ibis Reproductive Health
PRS Account Ibis Reproductive Health
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP