NCT02708446

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2014

Typical duration for phase_4

Geographic Reach
4 countries

4 active sites

Status
unknown

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

May 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

2.6 years

First QC Date

February 10, 2016

Last Update Submit

July 13, 2016

Conditions

Legally Induced Abortion Without Mention of Complication

Keywords

Second TrimesterAbortionMisoprostolSublingualBuccal

Outcome Measures

Primary Outcomes (2)

  • Rate of successful abortion by 24 hours

    Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.

    24 hours following the start of misoprostol

  • Rate of successful abortion by 48 hours

    Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.

    48hours following the start of misoprostol

Secondary Outcomes (6)

  • Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).

    48 hours

  • Percentage of patients requiring provision of additional interventions.

    from first drug dose to complete expulsion as documented on study forms, up to 72 hours

  • Total number of doses of misoprostol.

    from first drug dose to complete expulsion as documented on study forms, up to 72 hours

  • Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment

    1 month

  • Pain scale (1-7) as reported by women on questionnaire

    from first drug dose to complete expulsion as documented on study forms, up to 72 hours

  • +1 more secondary outcomes

Study Arms (2)

Sublingual misoprostol

ACTIVE COMPARATOR

200mg mifepristone + 400mcg sublingual misoprostol q3h

Drug: MifepristoneDrug: Sublingual misoprostol

Buccal misoprostol

ACTIVE COMPARATOR

200mg mifepristone + 400mcg buccal misoprostol q3h

Drug: MifepristoneDrug: Buccal misoprostol

Interventions

MifepristoneDRUG

200mg oral mifepristone to both study arms

Also known as: miropristone, Mifeprex, Mifegyne
Buccal misoprostolSublingual misoprostol
Buccal misoprostolDRUG

doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone

Also known as: cytotec
Buccal misoprostol
Sublingual misoprostolDRUG

doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

Also known as: cytotec
Sublingual misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)

Yerevan, Armenia

RECRUITING

Kathmandu Medical College

Kathmandu, Nepal

RECRUITING

La Rabta Maternity Hospital

Tunis, Tunisia

RECRUITING

Clinic No. 2, Tashkent Medical Academy

Tashkent, Uzbekistan

RECRUITING

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

March 15, 2016

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

NE(1)AR(1)UZ(1)TU(1)