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

NCT02745093 | Unknown Phase 4

• 1 other identifier: MSI-6103
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 3

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.

Conditions

Medical Abortion

Keywords

Abortion induced; Patient Acceptance of Healthcare; safety; effectiveness; misoprostol; mifepristone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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

Study Arms (2)

64-84 days gestational age

EXPERIMENTAL

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; Drug: Misoprostol

57-63 days gestational age

NO INTERVENTION

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).

Interventions

Mifepristone DRUG

Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.

64-84 days gestational age

Misoprostol DRUG

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.

64-84 days gestational age

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ibis Reproductive Health: lead
• Marie Stopes International: collaborator

Study Sites (3)

Marie Stopes Mexico Azcapotzalco

Del. Azcapotzalco, Mexico Distrito Federal, 02000, Mexico

Location

Marie Stopes Mexico Roma

Del. Cuauhtémoc, Mexico Distrito Federal, 06760, Mexico

Location

Marie Stopes Mexico Pedregal

Del. Tlalpan, Mexico Distrito Federal, 14010, Mexico

Location

Related 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 Curacao. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):61-6. doi: 10.3109/13625187.2011.555568. Epub 2011 Feb 9.

  PMID: 21303309 BACKGROUND

• 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.

  PMID: 26241251 BACKGROUND

• 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.

  PMID: 24314910 BACKGROUND

• 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.

  PMID: 10426609 BACKGROUND

• 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.

  PMID: 15854631 BACKGROUND

• 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.

  PMID: 16045525 BACKGROUND

• 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.

  PMID: 22071804 BACKGROUND

• 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.

  PMID: 21556304 BACKGROUND

• 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/

  PMID: 23700650 BACKGROUND

• 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.

  PMID: 23090524 BACKGROUND

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Mifepristone; Misoprostol

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Daniel Grossman, MD

  Ibis Reproductive Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Candelas

CONTACT

++ 52 55 5265 5041; antonio.candelas@mariestopes.org.mx

Araceli Lopez Nava Vazquez

CONTACT

++ 52 55 5543 0000; araceli.lopeznava@mariestopes.org.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: April 20, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

ME (3)