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Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

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: NCT02342002
Recruitment Status : Terminated (lack of funding)
First Posted : January 19, 2015
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

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

Detailed Description:
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mifepristone-misoprostol regimen
After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
Drug: Mifepristone
Mifepristone for treatment of missed abortion

Drug: Misoprostol
Misoprostol for treatment of missed abortion

Placebo Comparator: Misoprostol alone regimen
After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
Drug: Misoprostol
Misoprostol for treatment of missed abortion




Primary Outcome Measures :
  1. Rate of successful evacuation of the uterus [ Time Frame: 1 week after treatment ]
    uterine evacuation without the need for uterine aspiration or other surgery


Secondary Outcome Measures :
  1. Rate of successful evacuation without any additional intervention [ Time Frame: 1 week after treatment ]
    uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention

  2. Excessive bleeding or a complication for which a woman received treatment [ Time Frame: 30 days after treatment ]
  3. Induction expulsion interval after misoprostol administration [ Time Frame: one week follow-up ]
    time interval between misoprostol administration and the expulsion

  4. Acceptability of assigned method to women [ Time Frame: one week follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ultrasound examination demonstrating:

    1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
    2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
  • If fetus exists, fetal size less than 12 weeks+6 days
  • Closed cervical os
  • Eligible to consent for research according to local regulations

Exclusion Criteria:

  • Active bleeding at enrollment and/or history of bleeding within the prior week
  • Allergies or other contraindications to the use of mifepristone or misoprostol
  • Suspected ectopic pregnancy
  • History of trophoblastic disease
  • Coagulation disorder and/or currently taking anticoagulants
  • Any serious medical condition

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): NCT02342002


Locations
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Argentina
Hospital Nacional Profesor Alejandro Posadas
Buenos Aires, Argentina
Gabon
CHU Libreville
Libreville, Gabon
Mexico
Hospital General Valle Ceylan
Tlalnepantla, Mexico
Pakistan
Agha Khan University Hospital
Karachi, Pakistan
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02342002    
Other Study ID Numbers: 1015
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: November 2018
Keywords provided by Gynuity Health Projects:
mifepristone
misoprostol
obstetrics
reproductive health
pregnancy
abortion
missed abortion
Additional relevant MeSH terms:
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Abortion, Missed
Abortion, Spontaneous
Pregnancy Complications
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