NCT00997347

Brief Summary

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

Geographic Reach
5 countries

12 active sites

Status
completed

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

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

2.6 years

First QC Date

October 1, 2009

Last Update Submit

June 28, 2012

Conditions

Medical Abortion

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion

    7-36 days

Secondary Outcomes (4)

  • Proportion of individual side effects experienced by participants

    7-14 days

  • Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)

    7-14 days

  • Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began

    7-14 days

  • Average number of missed days of work or school due to the abortion procedure

    7-14 days

Study Arms (2)

64-70 days' gestational age

EXPERIMENTAL

Women whose pregnancies are estimated to have a gestational age of 64-70 days

Drug: Mifepristone and misoprostol

57-63 days' gestational age

NO INTERVENTION

Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range.)

Interventions

Mifepristone and misoprostolDRUG

200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone

64-70 days' gestational age

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intrauterine pregnancy of greater than 56 days and less than 71 days
  • eligible for medical abortion according to study doctor assessment
  • willing and able to sign consent forms
  • speak English or Spanish (in US sites); speak the local language(s) (in international sites)
  • agree to comply with the study procedures and visit schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Presidential Women's Center

West Palm Beach, Florida, 33407, United States

Location

Family Planning Associates Medical Group

Chicago, Illinois, 60630, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Planned Parenthood, Minnesota, North Dakota, South Dakota

Saint Paul, Minnesota, 55116, United States

Location

Planned Parenthood of New York City

New York, New York, 10012, United States

Location

Planned Parenthood, Central Texas

Waco, Texas, 76710, United States

Location

Zhordania Institute of Human Reproduction

Tbilisi, Georgia

Location

Government Medical College (GMC)

Nagpur, India

Location

Naval Nursing Home

Solapur, India

Location

La Rabta Maternity Hospital

Tunis, Tunisia

Location

Central District Maternity House

Odesa, Ukraine

Location

Maternity Hospital No.2

Simferopol, Ukraine

Location

Related Publications (1)

  • Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.

    PMID: 23090524DERIVED

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yael Swica, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Hillary Bracken, PhD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 19, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

UA(2)TU(1)IN(2)US(6)GE(1)