NCT02342002

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
4 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 15, 2019

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

January 9, 2015

Last Update Submit

January 11, 2019

Conditions

Missed AbortionPregnancy

Keywords

mifepristonemisoprostolobstetricsreproductive healthpregnancyabortionmissed abortion

Outcome Measures

Primary Outcomes (1)

  • Rate of successful evacuation of the uterus

    uterine evacuation without the need for uterine aspiration or other surgery

    1 week after treatment

Secondary Outcomes (4)

  • Rate of successful evacuation without any additional intervention

    1 week after treatment

  • Excessive bleeding or a complication for which a woman received treatment

    30 days after treatment

  • Induction expulsion interval after misoprostol administration

    one week follow-up

  • Acceptability of assigned method to women

    one week follow-up

Study Arms (2)

Mifepristone-misoprostol regimen

EXPERIMENTAL

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: MifepristoneDrug: Misoprostol

Misoprostol alone regimen

PLACEBO COMPARATOR

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

Interventions

MifepristoneDRUG

Mifepristone for treatment of missed abortion

Mifepristone-misoprostol regimen
MisoprostolDRUG

Misoprostol for treatment of missed abortion

Mifepristone-misoprostol regimenMisoprostol alone regimen

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ultrasound examination demonstrating:
  • Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Nacional Profesor Alejandro Posadas

Buenos Aires, Argentina

Location

CHU Libreville

Libreville, Gabon

Location

Hospital General Valle Ceylan

Tlalnepantla, Mexico

Location

Agha Khan University Hospital

Karachi, Pakistan

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

MifepristoneMisoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Hillary Bracken, PhD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 15, 2019

Record last verified: 2018-11

Locations

GA(1)AR(1)ME(1)PA(1)