ContraceptionPPFP-IZNCT01115361
Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
A study testing Family planning for postpartum women in people with Contraception, run by FHI 360 at 1 site in Rwanda.
Trial summary
The purpose of this study is to determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Family planning for postpartum women
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteRwanda
- Study dates
- Feb 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clients:
- adult women, aged 21 years and older, or married women ages 18 to 20 who have achieved legal majority status by emancipation due to marriage,
- bring their infants between the ages 6-12 months to immunization services at study sites
- Providers:
- all health care providers who currently provide immunization services to infants and/or family planning services within the selected facilities.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
The purpose of this study is to determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.
Read the detailed description
Study Goal:
To determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.
The Intervention:
- Brief, concise messages conveyed to women during group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.
B.IEC materials such as posters and brochures that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.
C.Use of a screening tool (Appendix A) to assess pregnancy risk for postpartum women coupled with a brief counseling message depending upon risk classification which includes referral to FP services for those currently or soon-to-be at-risk of pregnancy.
D.Convenient offer of FP services to women attending vaccination services for their infants either concurrently with vaccination services, or at the same facility and on the same day, but at a different time from vaccination services.
Study Design:
Experimental, two-group (intervention/control) pretest (pre-intervention) /posttest (post-intervention) design 12 month intervention period. A mid-course collection of process data will also be conducted at 6 months to assess the degree to which the intervention is being implemented as intended and to provide an opportunity for corrective action if needed.
Participants: Women attending vaccination services for their infants, and vaccination and FP providers
- Conditions
- Contraception
- Being tested
- Family planning for postpartum women
- Keywords
- family planning, postpartum, immunization, integration, Contraceptive behavior
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family planning for postpartum womenBehavioural
A.Group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.
- IEC materials that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.
- Use of a screening tool to assess pregnancy risk for postpartum women coupled with a brief counseling message and referral to FP services.
D.Convenient offer of FP services to women attending vaccination services for their infants.
| Study group | Role | What they receive |
|---|---|---|
| PPFP in child immunization | Experimental | Women attending immunization services for their infant will receive educational brochures, group education and individual counseling on the benefits of the health timing and spacing of births,, pregnancy risk and return to fertility during the extended postpartum period (12 months), and referral to family planning services for those who are interested. Receives: Behavioral: Family planning for postpartum women |
| Control - Standard of care | No intervention | The control arm will receive standard of care infant immunization services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of a modern contraceptive method among postpartum women
The outcome variable is a dichotomous variable - use of modern FP method: yes/no
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Rwanda
- Responsible party
- Sponsor
- Investigators
- Lisa S Dulli, PhD, MHS, Principal investigator, FHI 360Steve Sortijas, MPH, Study director, FHI 360Fidèle Ngabo, MD, MPH, Principal investigator, Ministry of Health, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115361
- Sponsor's protocol ID
- 890028
- Acronym
- PPFP-IZ
- Status last verified
- Mar 2012
- First submitted
- 28 Apr 2010
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
- ClinicalTrials.gov ID
- NCT01115361
- Acronym / sponsor ID
- PPFP-IZ / 890028
- Conditions
- Contraception
- Keywords
- family planning, postpartum, immunization, integration, Contraceptive behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Ministry of Health, Rwanda
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
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 the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.
Detailed description
Study Goal:
To determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.
The Intervention:
- Brief, concise messages conveyed to women during group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.
B.IEC materials such as posters and brochures that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.
C.Use of a screening tool (Appendix A) to assess pregnancy risk for postpartum women coupled with a brief counseling message depending upon risk classification which includes referral to FP services for those currently or soon-to-be at-risk of pregnancy.
D.Convenient offer of FP services to women attending vaccination services for their infants either concurrently with vaccination services, or at the same facility and on the same day, but at a different time from vaccination services.
Study Design:
Experimental, two-group (intervention/control) pretest (pre-intervention) /posttest (post-intervention) design 12 month intervention period. A mid-course collection of process data will also be conducted at 6 months to assess the degree to which the intervention is being implemented as intended and to provide an opportunity for corrective action if needed.
Participants: Women attending vaccination services for their infants, and vaccination and FP providers
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPFP in child immunization | Experimental | Behavioral: Family planning for postpartum womenWomen attending immunization services for their infant will receive educational brochures, group education and individual counseling on the benefits of the health timing and spacing of births,, pregnancy risk and return to fertility during the extended postpartum period (12 months), and referral to family planning services for those who are interested. |
| Control - Standard of care | No intervention | –The control arm will receive standard of care infant immunization services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult women, aged 21 years and older, or married women ages 18 to 20 who have achieved legal majority status by emancipation due to marriage,
- bring their infants between the ages 6-12 months to immunization services at study sites
- all health care providers who currently provide immunization services to infants and/or family planning services within the selected facilities.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Family planning for postpartum womenA.Group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period. B. IEC materials that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women. C. Use of a screening tool to assess pregnancy risk for postpartum women coupled with a brief counseling message and referral to FP services. D.Convenient offer of FP services to women attending vaccination services for their infants. | Behavioural | PPFP in child immunization |
Primary outcome
Use of a modern contraceptive method among postpartum women
Time frame: 1 year
The outcome variable is a dichotomous variable - use of modern FP method: yes/no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
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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.
Lisa S Dulli, PhD, MHS principal investigator
FHI 360
Steve Sortijas, MPH study director
FHI 360
Fidèle Ngabo, MD, MPH principal investigator
Ministry of Health, Rwanda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family planning for postpartum women in people with Contraception, run by FHI 360 at 1 site in Rwanda.
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 5 inclusion and 0 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 29 Mar 2012. 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 Rwanda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of a modern contraceptive method among postpartum women (time frame: 1 year). 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 29 Mar 2012.