NCT01902485

Brief Summary

This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
937

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Typical duration for phase_4

Geographic Reach
2 countries

8 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, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

2.4 years

First QC Date

July 15, 2013

Last Update Submit

March 3, 2016

Conditions

Keywords

ContraceptionMedical AbortionImplantInjectableQuickstart

Outcome Measures

Primary Outcomes (2)

  • Medical Abortion Failure

    One month after enrollment

  • Repeat Pregnancy

    6 months after enrollment

Study Arms (2)

Quickstart

ACTIVE COMPARATOR

Immediate start

Other: Timing of Contraceptive Initiation in Medical Abortion

Afterstart

ACTIVE COMPARATOR

Delayed start

Other: Timing of Contraceptive Initiation in Medical Abortion

Interventions

Eligibility Criteria

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

You may qualify if:

  • Women having medical abortion desiring progestin-based contraceptives (injectables or implants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Planned Parenthood of the Pacific Southwest

Chula Vista, California, United States

Location

Planned Parenthood Northern California

Eureka, California, United States

Location

Planned Parenthood of Southern New England

Stamford, Connecticut, United States

Location

Bayview Medical Center

Baltimore, Maryland, United States

Location

Boston Medical Center

Boston, Massachusetts, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, United States

Location

Centro de Salud Beatriz Velasco de Aleman

Mexico City, Mexico

Location

Centro de Salud Santa Catarina

Mexico City, Mexico

Location

Related Publications (2)

  • Raymond EG, Weaver MA, Louie KS, Tan YL, Bousieguez M, Arangure-Peraza AG, Lugo-Hernandez EM, Sanhueza P, Goldberg AB, Culwell KR, Kaplan C, Memmel L, Sonalkar S, Jamshidi R, Winikoff B. Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):739-45. doi: 10.1097/AOG.0000000000001627.

  • Raymond EG, Weaver MA, Tan YL, Louie KS, Bousieguez M, Lugo-Hernandez EM, Arangure-Peraza AG, Sanhueza P, Kaplan C, Sonalkar S, Goldberg AB, Culwell KR, Memmel L, Jamshidi R, Winikoff B. Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):306-12. doi: 10.1097/AOG.0000000000001274.

Study Design

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

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 18, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations