Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01768299
First received: January 11, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.


Condition Intervention Phase
Complete Uterine Evacuation After Use of Study Drugs
Drug: Mifepristone
Drug: Misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
    Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.


Secondary Outcome Measures:
  • Induction to abortion interval [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
    Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.

  • Women's acceptability of the assigned method. [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
  • Rate of fetal expulsion [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
    Defined as fetal expulsion with study drug alone.

  • Provision of additional interventions [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
    For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs

  • Time interval from the mifepristone dose to abortion [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
    Defined as length of time from initiation of mifepristone to complete abortion achieved.

  • Total dose of misoprostol administered [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]

Enrollment: 504
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone at home 24 hours before miso dosing starts

All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.

Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.

Drug: Mifepristone
200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
Experimental: Mifepristone and first dose of misoprostol simultaneously.

Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.

Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled.

Drug: Misoprostol
200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Closed cervical os and no vaginal bleeding
  • Live fetus at time of presentation for service
  • No contraindications to medical abortion and study procedures, according to provider
  • Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
  • Willing to follow study procedures

Exclusion Criteria:

  • Known previous transmural uterine incision
  • > 5 parity
  • Signs and symptoms of infection
  • Any contraindications to vaginal delivery, including placenta previa
  • Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768299

Locations
Vietnam
Binh duong Obstetrics and Newborn Hospital
Ho Chi Minh City, Binh Duong Province, Vietnam
National Ob-Gyn Hospital
Hanoi, Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Jennifer Blum, MPH Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Dina Abbas, MPH Gynuity Health Projects
Principal Investigator: Nguyen thi Ngoc, MD Hung Vuong Hospital
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01768299     History of Changes
Other Study ID Numbers: 1008
Study First Received: January 11, 2013
Last Updated: May 12, 2014
Health Authority: Vietnam: Scientific Committee, Hung Vuong Hospital
Additional IRB: National Hospital OB-GYN, Hanoi, Vietnam

Keywords provided by Gynuity Health Projects:
abortion
medical abortion
mifepristone
misoprostol

Additional relevant MeSH terms:
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on October 01, 2014