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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Medical Abortion Drug: Mifepristone Drug: Misoprostol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 648 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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).



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group [ Time Frame: 2-4 weeks ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group [ Time Frame: 2-4 weeks ]
  8. Number of participants requiring an unscheduled clinic visit, by gestational age group [ Time Frame: 2-4 weeks ]
  9. Number of participants who called the helpline, by gestational age group [ Time Frame: 2-4 weeks ]
  10. Time to expulsion in days, by gestational age group [ Time Frame: 2-4 weeks ]
  11. Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group [ Time Frame: 2-4 weeks ]
  12. Duration of heavy bleeding, by gestational age group [ Time Frame: 2-4 weeks ]
  13. Duration of work or school missed, by gestational age group [ Time Frame: 2-4 weeks ]
  14. Pain reliever use [ Time Frame: 2-4 weeks ]
  15. Satisfied or very satisfied with abortion method, by gestational age group [ Time Frame: 2-4 weeks ]
  16. Would choose medical abortion again instead of surgical, by gestational age group [ Time Frame: 2-4 weeks ]
  17. Would recommend abortion method to a friend, by gestational age group [ Time Frame: 2-4 weeks ]
  18. Proportion of participants who saw products of pregnancy, by gestational age group [ Time Frame: 2-4 weeks ]
  19. 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 ]
  20. Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention [ Time Frame: 2-4 weeks ]
  21. Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention [ Time Frame: 2-4 weeks ]
  22. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745093


Contacts
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Contact: Antonio Candelas ++ 52 55 5265 5041 antonio.candelas@mariestopes.org.mx
Contact: Araceli Lopez Nava Vazquez ++ 52 55 5543 0000 ext 101 araceli.lopeznava@mariestopes.org.mx

Locations
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Mexico
Marie Stopes Mexico Azcapotzalco
Del. Azcapotzalco, Mexico Distrito Federal, Mexico, 02000
Marie Stopes Mexico Roma
Del. Cuauhtémoc, Mexico Distrito Federal, Mexico, 06760
Marie Stopes Mexico Pedregal
Del. Tlalpan, Mexico Distrito Federal, Mexico, 14010
Sponsors and Collaborators
Ibis Reproductive Health
Marie Stopes International
Investigators
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Principal Investigator: Daniel Grossman, MD Ibis Reproductive Health
Publications:

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Responsible Party: Ibis Reproductive Health
ClinicalTrials.gov Identifier: NCT02745093    
Other Study ID Numbers: MSI-6103
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Keywords provided by Ibis Reproductive Health:
Abortion induced
Patient Acceptance of Healthcare
safety
effectiveness
misoprostol
mifepristone
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents