Post Abortion Care
Conditions
Keywords
Ambulatory Care Facilities, abortion care, contraception, counseling, outpatient clinic
Brief 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.
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.
Interventions
BEHAVIORALPersonalized 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.
Sponsors
Instituto Materno Infantil Prof. Fernando Figueira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up | 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 |
| Correct Use of the Method | within the first 6 months after intervention | the correct use was considerer by each methods according the prescription. |
| Chosen Contraceptive Method After Counseling | after the contraceptive counseling | the type of contraceptive methods chosen by women following after counseling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancies Among All Women | within the first six months after intervention | — |
| Satisfaction With the Used Contraceptive Method | During the 6-month Follow-up | the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied. |
Countries
Brazil
Participant flow
Recruitment details
The recruitment period was between July 2008 and September 2009. All women who had an abortion in any of the five public maternities in Recife were invited to participate.
Pre-assignment details
Of the 403 women invited, 310 attended the service. However 39 women were excluded because they did not agree to participate and 25 women did not fill the inclusion criteria, as for gestational trophoblastic disease, benign and malignant tumors of the uterus and uterine malformation.
Participants by arm
| Arm | Count |
|---|---|
| Personalized Contraceptive Counseling All 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. | 123 |
| Control All 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 | 123 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 59 |
Baseline characteristics
| Characteristic | Control | Personalized Contraceptive Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 11 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 115 Participants | 112 Participants | 227 Participants |
| Age Continuous | 27.6 years STANDARD_DEVIATION 6.8 | 26.2 years STANDARD_DEVIATION 6.8 | 26.6 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment Brazil | 123 participants | 123 participants | 246 participants |
| Sex: Female, Male Female | 123 Participants | 123 Participants | 246 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 37 | 0 / 48 |
Outcome results
Primary
Chosen Contraceptive Method After Counseling
the type of contraceptive methods chosen by women following after counseling
Time frame: after the contraceptive counseling
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Personalized Contraceptive Counseling | Chosen Contraceptive Method After Counseling | 123 participants |
| Control | Chosen Contraceptive Method After Counseling | 117 participants |
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
Time frame: after the contraceptive counseling and during the 6-month follow
Population: The analysis was by intention to treat in both groups. All the women were retained in their original assigned group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Personalized Contraceptive Counseling | Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up | 121 participants |
| Control | Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up | 86 participants |
Primary
Correct Use of the Method
the correct use was considerer by each methods according the prescription.
Time frame: within the first 6 months after intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Personalized Contraceptive Counseling | Correct Use of the Method | 121 participants |
| Control | Correct Use of the Method | 68 participants |
Secondary
Pregnancies Among All Women
Time frame: within the first six months after intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Personalized Contraceptive Counseling | Pregnancies Among All Women | 2 participants |
| Control | Pregnancies Among All Women | 12 participants |
Secondary
Satisfaction With the Used Contraceptive Method
the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.
Time frame: During the 6-month Follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Personalized Contraceptive Counseling | Satisfaction With the Used Contraceptive Method | 99 participants |
| Control | Satisfaction With the Used Contraceptive Method | 41 participants |