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

Medical Abortion Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02745093
• Other study ID #: MSI-6103
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 7, 2015
• Last updated: June 16, 2016
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Ibis Reproductive Health
• Contact: Antonio Candelas
• Phone: ++ 52 55 5265 5041
• Email: antonio.candelas[@]mariestopes.org.mx
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 648
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Abortion

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Marie Stopes Mexico Azcapotzalco	Del. Azcapotzalco	Mexico Distrito Federal
Mexico	Marie Stopes Mexico Roma	Del. Cuauhtémoc	Mexico Distrito Federal
Mexico	Marie Stopes Mexico Pedregal	Del. Tlalpan	Mexico Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Ibis Reproductive Health	Marie Stopes International

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

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 Curaçao. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):61-6. doi: 10.3109/13625187.2011.555568. Epub 2011 Feb 9. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Kulier R, Kapp N, Gülmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD002855. doi: 10.1002/14651858.CD002855.pub4. Review. — View 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. Review. — View Citation

Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. — View 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: http://10.1097/AOG.0b013e31826c315f. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group		2-4 weeks	Yes
Secondary	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	Yes
Secondary	Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group		2-4 weeks	Yes
Secondary	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	Yes
Secondary	Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group		2-4 weeks	Yes
Secondary	Number of participants requiring an unscheduled clinic visit, by gestational age group		2-4 weeks	Yes
Secondary	Number of participants who called the helpline, by gestational age group		2-4 weeks	Yes
Secondary	Time to expulsion in days, by gestational age group		2-4 weeks	No
Secondary	Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group		2-4 weeks	Yes
Secondary	Duration of heavy bleeding, by gestational age group		2-4 weeks	Yes
Secondary	Duration of work or school missed, by gestational age group		2-4 weeks	No
Secondary	Pain reliever use		2-4 weeks	No
Secondary	Satisfied or very satisfied with abortion method, by gestational age group		2-4 weeks	No
Secondary	Would choose medical abortion again instead of surgical, by gestational age group		2-4 weeks	No
Secondary	Would recommend abortion method to a friend, by gestational age group		2-4 weeks	No
Secondary	Proportion of participants who saw products of pregnancy, by gestational age group		2-4 weeks	No
Secondary	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	No
Secondary	Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention		2-4 weeks	No
Secondary	Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention		2-4 weeks	No
Secondary	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	No