Clinical trial NCT02745093: Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Medical Abortion
Keywords: Abortion induced
Patient Acceptance of Healthcare
safety
effectiveness
misoprostol
mifepristone
Lead sponsor: Ibis Reproductive Health
Sponsor class: OTHER
Collaborators: name: Marie Stopes International
First posted: 2016-04-20
Enrollment: 648
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with complete abortion without surgical intervention by day 30 from mifepristone administration, regardless of misoprostol dosing, by gestational age group
timeFrame: 2-4 weeks
Secondary outcomes:
measure: 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
timeFrame: 2-4 weeks
measure: 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
timeFrame: 2-4 weeks
measure: Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group
timeFrame: 2-4 weeks
measure: Number of participants requiring surgical intervention to complete an abortion due to the presence of a persistent non-viable sac, by gestational age group
timeFrame: 2-4 weeks
measure: Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group
timeFrame: 2-4 weeks
measure: 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
timeFrame: 2-4 weeks
measure: Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group
timeFrame: 2-4 weeks
measure: Number of participants requiring an unscheduled clinic visit, by gestational age group
timeFrame: 2-4 weeks
measure: Number of participants who called the helpline, by gestational age group
timeFrame: 2-4 weeks
measure: Time to expulsion in days, by gestational age group
timeFrame: 2-4 weeks
measure: Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group
timeFrame: 2-4 weeks
measure: Duration of heavy bleeding, by gestational age group
timeFrame: 2-4 weeks
measure: Duration of work or school missed, by gestational age group
timeFrame: 2-4 weeks
measure: Pain reliever use
timeFrame: 2-4 weeks
measure: Satisfied or very satisfied with abortion method, by gestational age group
timeFrame: 2-4 weeks
measure: Would choose medical abortion again instead of surgical, by gestational age group
timeFrame: 2-4 weeks
measure: Would recommend abortion method to a friend, by gestational age group
timeFrame: 2-4 weeks
measure: Proportion of participants who saw products of pregnancy, by gestational age group
timeFrame: 2-4 weeks
measure: Proportion of participants who saw products of pregnancy who reported feelings as: nothing/no feeling, relieved, sad, uncomfortable, other, by gestational group
timeFrame: 2-4 weeks
measure: Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention
timeFrame: 2-4 weeks
measure: Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention
timeFrame: 2-4 weeks
measure: 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
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Del. Azcapotzalco
country: Mexico
facility: Marie Stopes Mexico Azcapotzalco
state: Mexico Distrito Federal
city: Del. Cuauhtémoc
country: Mexico
facility: Marie Stopes Mexico Roma
state: Mexico Distrito Federal
city: Del. Tlalpan
country: Mexico
facility: Marie Stopes Mexico Pedregal
state: Mexico Distrito Federal
Study officials:
affiliation: Ibis Reproductive Health
name: Daniel Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boersma AA, Meyboom-de Jong B, Kleiverda G. Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of amenorrhoea in a general practice in Curacao. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):61-6. doi: 10.3109/13625187.2011.555568. Epub 2011 Feb 9.
citation: Chen MJ, Creinin MD. Mifepristone With Buccal Misoprostol for Medical Abortion: A Systematic Review. Obstet Gynecol. 2015 Jul;126(1):12-21. doi: 10.1097/AOG.0000000000000897.
citation: Gomperts R, van der Vleuten K, Jelinska K, da Costa CV, Gemzell-Danielsson K, Kleiverda G. Provision of medical abortion using telemedicine in Brazil. Contraception. 2014 Feb;89(2):129-33. doi: 10.1016/j.contraception.2013.11.005. Epub 2013 Nov 12.
citation: Gouk EV, Lincoln K, Khair A, Haslock J, Knight J, Cruickshank DJ. Medical termination of pregnancy at 63 to 83 days gestation. Br J Obstet Gynaecol. 1999 Jun;106(6):535-9. doi: 10.1111/j.1471-0528.1999.tb08320.x.
citation: Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks' gestation: a review of 1076 consecutive cases. Contraception. 2005 May;71(5):327-32. doi: 10.1016/j.contraception.2004.10.015.
citation: Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005 Aug;112(8):1102-8. doi: 10.1111/j.1471-0528.2005.00638.x.
citation: Kulier R, Kapp N, Gulmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD002855. doi: 10.1002/14651858.CD002855.pub4.
citation: Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ. 2011 May 1;89(5):360-70. doi: 10.2471/BLT.10.084046. Epub 2011 Mar 4.
citation: Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/
citation: Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.