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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00756314
Other study ID # APA-1
Secondary ID
Status Completed
Phase N/A
First received September 19, 2008
Last updated October 6, 2010
Start date July 2008
Est. completion date September 2009

Study information

Verified date March 2010
Source Instituto Materno Infantil Prof. Fernando Figueira
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 246
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil IMIP - Instituto Materno Infantil Prof Fernando Figueira Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up 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 Yes
Primary Correct Use of the Method the correct use was considerer by each methods according the prescription. within the first 6 months after intervention Yes
Primary Chosen Contraceptive Method After Counseling the type of contraceptive methods chosen by women following after counseling after the contraceptive counseling Yes
Secondary Pregnancies Among All Women within the first six months after intervention Yes
Secondary Satisfaction With the Used Contraceptive Method the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied. During the 6-month Follow-up Yes