Contraceptive Counseling Following an Abortion (APA)

This study has been completed.
Sponsor:
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00756314
First received: September 19, 2008
Last updated: October 6, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention
Post Abortion Care
Behavioral: Personalized contraceptive counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Contraceptive Counseling of Women Following an Abortion in Recife, Brasil: a Randomized Controlled Intervention Study.

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up [ Time Frame: after the contraceptive counseling and during the 6-month follow ] [ Designated as safety issue: Yes ]
    The acceptability and the use of contraceptives during the follow-up period was defined as just "yes" or "no"

  • Correct Use of the Method [ Time Frame: within the first 6 months after intervention ] [ Designated as safety issue: Yes ]
    the correct use was considerer by each methods according the prescription.

  • Chosen Contraceptive Method After Counseling [ Time Frame: after the contraceptive counseling ] [ Designated as safety issue: Yes ]
    the type of contraceptive methods chosen by women following after counseling


Secondary Outcome Measures:
  • Pregnancies Among All Women [ Time Frame: within the first six months after intervention ] [ Designated as safety issue: Yes ]
  • Satisfaction With the Used Contraceptive Method [ Time Frame: During the 6-month Follow-up ] [ Designated as safety issue: Yes ]
    the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.


Enrollment: 246
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756314

Locations
Brazil
IMIP - Instituto Materno Infantil Prof Fernando Figueira
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Study Director: Ariani I Souza, PhD IMIP
  More Information

Additional Information:
No publications provided

Responsible Party: Ana Laura Carneiro Gomes Ferreira, IMIP
ClinicalTrials.gov Identifier: NCT00756314     History of Changes
Other Study ID Numbers: APA-1
Study First Received: September 19, 2008
Results First Received: September 9, 2010
Last Updated: October 6, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Ambulatory Care Facilities
abortion care
contraception
counseling
outpatient clinic

Additional relevant MeSH terms:
Contraceptive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014