Post Abortion CareAPANCT00756314
Contraceptive Counseling Following an Abortion
A study testing Personalized contraceptive counseling in people with Post Abortion Care, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Abortion Care
- What is being tested?
- Personalized contraceptive counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Within the first 10 days (plus or minus 5 days) after an abortion
- Live in Recife or whereabouts in Recife(Brazil)
Who cannot join
- Clinical diagnosis of Gestational Trophoblastic Disease
- Women HIV positive
- Psychiatric pathology
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IMIP - Instituto Materno Infantil Prof Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Effectiveness of Contraceptive Counseling of Women Following an Abortion in Recife, Brasil: a Randomized Controlled Intervention Study.
The purpose of this study is to determine whether contraceptive counseling is effective on acceptance and use of methods in women following an abortion.
Read the 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.
- Conditions
- Post Abortion Care
- Being tested
- Personalized contraceptive counseling
- Keywords
- Ambulatory Care Facilities, abortion care, contraception, counseling, outpatient clinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized contraceptive counselingBehavioural
Also called Intervention group, Control group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Personalized contraceptive counseling |
| 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 Receives: Behavioral: Personalized contraceptive counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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.
Measured: within the first 6 months after intervention
Chosen Contraceptive Method After Counseling
the type of contraceptive methods chosen by women following after counseling
Measured: after the contraceptive counseling
Secondary outcomes (2)
Pregnancies Among All Women
Measured: 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.
Measured: During the 6-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Abortion CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Investigators
- Ariani I Souza, PhD, Study director, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756314
- Sponsor's protocol ID
- APA-1
- Acronym
- APA
- Status last verified
- Mar 2010
- First submitted
- 19 Sep 2008
- Last updated
- 13 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Contraceptive Counseling of Women Following an Abortion in Recife, Brasil: a Randomized Controlled Intervention Study.
- ClinicalTrials.gov ID
- NCT00756314
- Acronym / sponsor ID
- APA / APA-1
- Conditions
- Post Abortion Care
- Keywords
- Ambulatory Care Facilities, abortion care, contraception, counseling, outpatient clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 30 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized contraceptive counseling | Experimental | Behavioral: Personalized contraceptive counselingAll 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 | Behavioral: Personalized contraceptive counselingAll 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 |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Within the first 10 days (plus or minus 5 days) after an abortion
- Live in Recife or whereabouts in Recife(Brazil)
Key exclusion criteria (3 listed)
- Clinical diagnosis of Gestational Trophoblastic Disease
- Women HIV positive
- Psychiatric pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized contraceptive counselingAlso: Intervention group, Control groupThe 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. | Behavioural | Control, Personalized contraceptive counseling |
Primary outcome
Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up
Time frame: 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
Time frame: within the first 6 months after intervention
the correct use was considerer by each methods according the prescription.
Chosen Contraceptive Method After Counseling
Time frame: after the contraceptive counseling
the type of contraceptive methods chosen by women following after counseling
2 secondary outcomes
Pregnancies Among All Women
Time frame: within the first six months after intervention
Satisfaction With the Used Contraceptive Method
Time frame: During the 6-month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about the study location (sponsor)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariani I Souza, PhD study director
IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized contraceptive counseling in people with Post Abortion Care, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up (time frame: after the contraceptive counseling and during the 6-month follow). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.