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Trial record 21 of 59 for:    abortion , gynuity

A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

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ClinicalTrials.gov Identifier: NCT02708446
Recruitment Status : Unknown
Verified July 2016 by Gynuity Health Projects.
Recruitment status was:  Recruiting
First Posted : March 15, 2016
Last Update Posted : July 14, 2016
Sponsor:
Collaborators:
La Rabta Maternity Hospital
Republican Institute of RH, Perinatology, and Ob/Gyn
Kathmandu Medical College and Teaching Hospital
Clinic No. 2 of Tashkent Medical Academy
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Condition or disease Intervention/treatment Phase
Legally Induced Abortion Without Mention of Complication Drug: Mifepristone Drug: Buccal misoprostol Drug: Sublingual misoprostol Phase 4

Detailed Description:
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)
Study Start Date : May 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sublingual misoprostol
200mg mifepristone + 400mcg sublingual misoprostol q3h
Drug: Mifepristone
200mg oral mifepristone to both study arms
Other Names:
  • miropristone
  • Mifeprex
  • Mifegyne

Drug: Sublingual misoprostol
doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone
Other Name: cytotec

Active Comparator: Buccal misoprostol
200mg mifepristone + 400mcg buccal misoprostol q3h
Drug: Mifepristone
200mg oral mifepristone to both study arms
Other Names:
  • miropristone
  • Mifeprex
  • Mifegyne

Drug: Buccal misoprostol
doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
Other Name: cytotec




Primary Outcome Measures :
  1. Rate of successful abortion by 24 hours [ Time Frame: 24 hours following the start of misoprostol ]
    Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.

  2. Rate of successful abortion by 48 hours [ Time Frame: 48hours following the start of misoprostol ]
    Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.


Secondary Outcome Measures :
  1. Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta). [ Time Frame: 48 hours ]
  2. Percentage of patients requiring provision of additional interventions. [ Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours ]
  3. Total number of doses of misoprostol. [ Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours ]
  4. Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: 1 month ]
  5. Pain scale (1-7) as reported by women on questionnaire [ Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours ]
  6. Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire [ Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet criteria to obtain abortion
  • Present with closed cervical os and no vaginal bleeding
  • Live fetus at time of presentation for service
  • Have no contraindications to study procedures, according to provider
  • Be able to consent to procedure, either by reading consent document or by having consent document read to her
  • Be willing to follow study procedures

Exclusion Criteria:

  • Known previous transmural uterine incision
  • Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
  • Any contraindications to vaginal delivery
  • Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

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): NCT02708446


Locations
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Armenia
b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG) Recruiting
Yerevan, Armenia
Contact: Ruzanna Abrahamyan, MD       r_abrahamyan@mail.ru   
Principal Investigator: Ruzanna Abrahamyan, MD         
Nepal
Kathmandu Medical College Recruiting
Kathmandu, Nepal
Contact: Chanda Karki, MD       chandakarki26@gmail.com   
Principal Investigator: Chanda Karki, MD         
Tunisia
La Rabta Maternity Hospital Recruiting
Tunis, Tunisia
Contact: Selma Hajri, MD       selma.hajri@gmail.com   
Principal Investigator: Ezzedine Sfar, MD         
Uzbekistan
Clinic No. 2, Tashkent Medical Academy Recruiting
Tashkent, Uzbekistan
Contact: Dilfuza Kurbanbekova, MD       wwcuzb@gmail.com   
Sponsors and Collaborators
Gynuity Health Projects
La Rabta Maternity Hospital
Republican Institute of RH, Perinatology, and Ob/Gyn
Kathmandu Medical College and Teaching Hospital
Clinic No. 2 of Tashkent Medical Academy
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02708446     History of Changes
Other Study ID Numbers: 1013
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Gynuity Health Projects:
Second Trimester
Abortion
Misoprostol
Sublingual
Buccal
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