Trial Outcomes & Findings for Contraceptive Counseling Following an Abortion (NCT NCT00756314)
NCT ID: NCT00756314
Last Updated: 2010-10-13
Results Overview
The acceptability and the use of contraceptives during the follow-up period was defined as just "yes" or "no"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
246 participants
Primary outcome timeframe
after the contraceptive counseling and during the 6-month follow
Results posted on
2010-10-13
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
123
|
|
Overall Study
COMPLETED
|
121
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
59
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
59
|
Baseline Characteristics
Contraceptive Counseling Following an Abortion
Baseline characteristics by cohort
| Measure |
Personalized Contraceptive Counseling
n=123 Participants
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.
|
Control
n=123 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
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
112 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
26.2 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
26.6 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
123 participants
n=5 Participants
|
123 participants
n=7 Participants
|
246 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after the contraceptive counseling and during the 6-month followPopulation: The analysis was by "intention to treat" in both groups. All the women were retained in their original assigned group.
The acceptability and the use of contraceptives during the follow-up period was defined as just "yes" or "no"
Outcome measures
| Measure |
Personalized Contraceptive Counseling
n=123 Participants
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.
|
Control
n=123 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
|
|---|---|---|
|
Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up
|
121 participants
|
86 participants
|
PRIMARY outcome
Timeframe: within the first 6 months after interventionthe correct use was considerer by each methods according the prescription.
Outcome measures
| Measure |
Personalized Contraceptive Counseling
n=123 Participants
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.
|
Control
n=123 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
|
|---|---|---|
|
Correct Use of the Method
|
121 participants
|
68 participants
|
PRIMARY outcome
Timeframe: after the contraceptive counselingthe type of contraceptive methods chosen by women following after counseling
Outcome measures
| Measure |
Personalized Contraceptive Counseling
n=123 Participants
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.
|
Control
n=123 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
|
|---|---|---|
|
Chosen Contraceptive Method After Counseling
|
123 participants
|
117 participants
|
SECONDARY outcome
Timeframe: within the first six months after interventionOutcome measures
| Measure |
Personalized Contraceptive Counseling
n=123 Participants
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.
|
Control
n=123 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
|
|---|---|---|
|
Pregnancies Among All Women
|
2 participants
|
12 participants
|
SECONDARY outcome
Timeframe: During the 6-month Follow-upthe satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.
Outcome measures
| Measure |
Personalized Contraceptive Counseling
n=123 Participants
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.
|
Control
n=123 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
|
|---|---|---|
|
Satisfaction With the Used Contraceptive Method
|
99 participants
|
41 participants
|
Adverse Events
Personalized Contraceptive Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ana Laura Carneiro Gomes Ferreira - MD
IMIP - Instituto Materno Infantil Prof. Fernando Figueira
Phone: +558121224779
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place