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The purpose of this study is to determine whether contraceptive counseling is effective on acceptance and use of methods in women following an abortion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized contraceptive counseling | Experimental | 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. |
|
| Control | No Intervention | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized contraceptive counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Correct Use of the Method | the correct use was considerer by each methods according the prescription. | within the first 6 months after intervention |
| Chosen Contraceptive Method After Counseling | the type of contraceptive methods chosen by women following after counseling | after the contraceptive counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancies Among All Women | within the first six months after intervention | |
| Satisfaction With the Used Contraceptive Method | the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariani I Souza, PhD | IMIP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMIP - Instituto Materno Infantil Prof Fernando Figueira | Recife | Pernambuco | 50070-550 | Brazil |
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| Label | URL |
|---|---|
| Click here for more information about the study location (sponsor) | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | The analysis was by "intention to treat" in both groups. All the women were retained in their original assigned group. | Posted | Number | participants | after the contraceptive counseling and during the 6-month follow | participants | Participants |
|
nausea and vomiting with use of the pill, one of the methods prescribed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The time of the follow up of six months after the abortion, not having the possibility to evaluate the effectiveness of the measurement in longer term.
However, this decision may have contributed to overestimate the intervention effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Laura Carneiro Gomes Ferreira - MD | IMIP - Instituto Materno Infantil Prof. Fernando Figueira | +558121224779 | analaura@imip.org.br |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
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| During the 6-month Follow-up |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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 |
|
|
| Primary | Correct Use of the Method | the correct use was considerer by each methods according the prescription. | Posted | Number | participants | within the first 6 months after intervention |
|
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| Secondary | Pregnancies Among All Women | Posted | Number | participants | within the first six months after intervention |
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| Primary | Chosen Contraceptive Method After Counseling | the type of contraceptive methods chosen by women following after counseling | Posted | Number | participants | after the contraceptive counseling |
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| Secondary | Satisfaction With the Used Contraceptive Method | the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied. | Posted | Number | participants | During the 6-month Follow-up |
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| 0 |
| 37 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 48 | 0 | 0 |
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| D008722 | Methods |