Contraceptive Counseling Following an Abortion (APA)

October 6, 2010 updated by: Instituto Materno Infantil Prof. Fernando Figueira

Effectiveness of Contraceptive Counseling of Women Following an Abortion in Recife, Brasil: a Randomized Controlled Intervention Study.

The purpose of this study is to determine whether contraceptive counseling is effective on acceptance and use of methods in women following an abortion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Contraceptive counseling is considered an essential component of post abortion care (PAC) programmes and it is recommended to prevent unintended pregnancies and unsafe, repeated abortions. Indeed, most maternal deaths related to unsafe abortions could be prevented by expanding and improving family planning provision.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • IMIP - Instituto Materno Infantil Prof Fernando Figueira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Within the first 10 days (plus or minus 5 days) after an abortion
  • Live in Recife or whereabouts in Recife(Brazil)

Exclusion Criteria:

  • Clinical diagnosis of Gestational Trophoblastic Disease
  • Women HIV positive
  • Psychiatric pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized contraceptive counseling
All 123 allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
Behavioral: Personalized contraceptive counseling
The intervention comprised a personalized and comprehensive (face-to-face) contraceptive counseling regarding to individual contraceptive history and needs. The counseling intervention was conducted by three trained gynecologists according to standard one day training.
Other Names:
  • Intervention group
  • Control group
No Intervention: Control
All 123 women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
Behavioral: Personalized contraceptive counseling
The intervention comprised a personalized and comprehensive (face-to-face) contraceptive counseling regarding to individual contraceptive history and needs. The counseling intervention was conducted by three trained gynecologists according to standard one day training.
Other Names:
  • Intervention group
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up
Time Frame: after the contraceptive counseling and during the 6-month follow
The acceptability and the use of contraceptives during the follow-up period was defined as just "yes" or "no"
after the contraceptive counseling and during the 6-month follow
Correct Use of the Method
Time Frame: within the first 6 months after intervention
the correct use was considerer by each methods according the prescription.
within the first 6 months after intervention
Chosen Contraceptive Method After Counseling
Time Frame: after the contraceptive counseling
the type of contraceptive methods chosen by women following after counseling
after the contraceptive counseling

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancies Among All Women
Time Frame: within the first six months after intervention
within the first six months after intervention
Satisfaction With the Used Contraceptive Method
Time Frame: During the 6-month Follow-up
the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.
During the 6-month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

  • Study Director: Ariani I Souza, PhD, IMIP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 6, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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