Postpartum PeriodNCT00949481
Increasing Family Planning Uptake Among Postpartum Women
A study testing Pregnancy Test and Job aid in people with Postpartum Period, run by FHI 360 at 2 sites in 2 countries.
Trial summary
The rationale for the study stems from the goal of reducing the very high unmet need for family planning among women in their first year postpartum. It is understood that the reason this need is so high in general is because postpartum women do not always "demand" family planning services, and family planning… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Pregnancy Test and Job aid
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,050 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2009to Aug 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- New and restarting family planning client (women seeking family planning service)
- Women with children 9-12 months of age attending immunization services
Who cannot join
- Attending immunization services with a child other than one's own
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Increasing Family Planning Uptake Among Postpartum Women: Testing Supply and Demand Solutions
The rationale for the study stems from the goal of reducing the very high unmet need for family planning among women in their first year postpartum. It is understood that the reason this need is so high in general is because postpartum women do not always "demand" family planning services, and family planning providers do not always "supply" services to postpartum (amenorrheic) women who do "demand" them. To address these supply and demand problems, corresponding supply and demand solutions will be tested.
- Demand Generating Strategy-Integrate into Immunization Services Following birth, return to fertility among postpartum women is dependent on many factors. These include time since last birth, breastfeeding intensity, and menstrual status. However, when and how fertility returns is often misunderstood by women. For instance, many women think that they can not get pregnant before their menses return, or that as long as they are breastfeeding they are protected from pregnancy. Educating women about their return to fertility following giving birth, and reminding women about the importance of birth spacing for their health and the health of their children is the focus of the demand-generating strategy. To reach postpartum women with these messages a demand generating activity at immunization clinics will be conducted, as immunization services are well attended. Based on the recommended immunization schedules for infants, women will make several visits to these clinics throughout the course of their first year postpartum, which provides an ideal opportunity to "hit" them with family planning messages more than once. To aid providers of immunization services in their delivery of family planning messages, a simple job aid was developed. The job aid takes providers through a series of 3 questions that will allow the provider to determine a mother's immediate risk for pregnancy (based on LAM criteria). If a woman is currently at risk for pregnancy, it prompts the provider to give a healthy timing and spacing message and to make a referral to the family planning clinic. If a woman is not currently at risk for pregnancy, the job aid helps the provider instruct the mother about when her risk for pregnancy will change, and therefore when she will need to seek family planning services to achieve proper birth spacing (should this be desirable to the mother). Also, in the family planning (FP) clinics that are located in the same facility as the immunization clinic, providers will be given the pregnancy checklist. This job-aid has already been researched (refer to citations). The purpose of providing it is to make sure that when women are referred to FP clinics by immunization providers, FP providers will supply them with a method. As a consequence, it hoped that by the time women are 9-12 months postpartum, there will be an increase in uptake of non-condom family planning methods.
- Supply Solution-Diversify Tools Available to Rule-Out Pregnancy The supply strategy focuses on giving providers the tools to give contraceptive methods to women who are amenorrheic. As recommended by the WHO, it is standard practice for FP providers to rule out the possibility of pregnancy before providing many types of methods to their clients. The presence of menses is often used to make this determination. However, return of menses can be delayed for many months in the postpartum period, limiting a provider's ability to supply postpartum women with contraceptive methods. To overcome this challenge, the Pregnancy Checklist was developed. It is a job-aid designed to rule out pregnancy based on client responses to questions concerning her recent sexual and reproductive history. Urine pregnancy testing is another viable option for ruling out pregnancy in non-menstruating FP clients, especially in situations where providers feel they cannot trust women to answer questions honestly. Thus, family planning clinics will be provided with free pregnancy test strips, and the change in same day uptake of FP methods will be measured.
Read more
Hypotheses
- Providing family planning messages to women attending immunization clinics with their child will cause them to seek family planning services in a greater proportion at 9-12 postpartum.
- The availability of free pregnancy testing will increase same day method provision for new and restarting family planning clients.
- Conditions
- Postpartum Period
- Being tested
- Pregnancy Test, Job aid
- Keywords
- postpartum, family planning, job aid, immunization, pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy TestOther
Free pregnancy test strips will be supplied to family planning clinics
Job aidOther
A new job-aid will be given to immunization providers that will guide them in assessing a mother's risk for pregnancy (based on LAM criteria), and guide them in making family planning referrals, including when a woman should start to use a family planning method if she wants to prevent pregnancy. The providers in immunization clinics will be asked to make such an assessment each time a woman has her baby vaccinated.
Additionally, in family planning clinics located in the same facilities as the immunization clinics, family planning providers will be trained to use and provided with the pregnancy checklist (see "links" for more information on the checklist)
| Study group | Role | What they receive |
|---|---|---|
| Supply | Experimental | In each country, this arm will be comprised of women attending family planning clinics within the 5 facilities randomized to this group. Receives: Other: Pregnancy Test |
| Demand | Experimental | In each country, this arm will be comprised of women attending immunization clinics within the 5 facilities randomized to this group. Receives: Other: Job aid |
| Control | No intervention | In each country, this arm will be comprised of women attending family planning and immunization clinics in 5 facilities randomized to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in current use of a modern family method among women attending immunization clinics for a child 9 to 12 months old between arms 2 and 3 of the study.
Measured: 13 months
The difference in immediate uptake of a modern family planning method (excluding condoms) among new and re-starting family planning clients between arms 1 and 3 of the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies 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
- 14,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana Health Services, Ministry of Health, Zambia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949481
- Sponsor's protocol ID
- 10083
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2009
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Stanback J, Qureshi Z, Sekadde-Kigondu C, Gonzalez B, Nutley T. Checklist for ruling out pregnancy among family-planning clients in primary care. Lancet. 1999 Aug 14;354(9178):566. doi: 10.1016/S0140-6736(99)01578-0.
PubMed 10470704Vance G, Janowitz B, Chen M, Boyer B, Kasonde P, Asare G, Kafulubiti B, Stanback J. Integrating family planning messages into immunization services: a cluster-randomized trial in Ghana and Zambia. Health Policy Plan. 2014 May;29(3):359-66. doi: 10.1093/heapol/czt022. Epub 2013 Apr 9.
PubMed 23570834
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Family Planning Uptake Among Postpartum Women: Testing Supply and Demand Solutions
- ClinicalTrials.gov ID
- NCT00949481
- Acronym / sponsor ID
- 10083
- Conditions
- Postpartum Period
- Keywords
- postpartum, family planning, job aid, immunization, pregnancy test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,050 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Ghana Health Services, Ministry of Health, Zambia
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Jul 2009 (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 rationale for the study stems from the goal of reducing the very high unmet need for family planning among women in their first year postpartum. It is understood that the reason this need is so high in general is because postpartum women do not always "demand" family planning services, and family planning providers do not always "supply" services to postpartum (amenorrheic) women who do "demand" them. To address these supply and demand problems, corresponding supply and demand solutions will be tested.
- Demand Generating Strategy-Integrate into Immunization Services Following birth, return to fertility among postpartum women is dependent on many factors. These include time since last birth, breastfeeding intensity, and menstrual status. However, when and how fertility returns is often misunderstood by women. For instance, many women think that they can not get pregnant before their menses return, or that as long as they are breastfeeding they are protected from pregnancy. Educating women about their return to fertility following giving birth, and reminding women about the importance of birth spacing for their health and the health of their children is the focus of the demand-generating strategy. To reach postpartum women with these messages a demand generating activity at immunization clinics will be conducted, as immunization services are well attended. Based on the recommended immunization schedules for infants, women will make several visits to these clinics throughout the course of their first year postpartum, which provides an ideal opportunity to "hit" them with family planning messages more than once. To aid providers of immunization services in their delivery of family planning messages, a simple job aid was developed. The job aid takes providers through a series of 3 questions that will allow the provider to determine a mother's immediate risk for pregnancy (based on LAM criteria). If a woman is currently at risk for pregnancy, it prompts the provider to give a healthy timing and spacing message and to make a referral to the family planning clinic. If a woman is not currently at risk for pregnancy, the job aid helps the provider instruct the mother about when her risk for pregnancy will change, and therefore when she will need to seek family planning services to achieve proper birth spacing (should this be desirable to the mother). Also, in the family planning (FP) clinics that are located in the same facility as the immunization clinic, providers will be given the pregnancy checklist. This job-aid has already been researched (refer to citations). The purpose of providing it is to make sure that when women are referred to FP clinics by immunization providers, FP providers will supply them with a method. As a consequence, it hoped that by the time women are 9-12 months postpartum, there will be an increase in uptake of non-condom family planning methods.
- Supply Solution-Diversify Tools Available to Rule-Out Pregnancy The supply strategy focuses on giving providers the tools to give contraceptive methods to women who are amenorrheic. As recommended by the WHO, it is standard practice for FP providers to rule out the possibility of pregnancy before providing many types of methods to their clients. The presence of menses is often used to make this determination. However, return of menses can be delayed for many months in the postpartum period, limiting a provider's ability to supply postpartum women with contraceptive methods. To overcome this challenge, the Pregnancy Checklist was developed. It is a job-aid designed to rule out pregnancy based on client responses to questions concerning her recent sexual and reproductive history. Urine pregnancy testing is another viable option for ruling out pregnancy in non-menstruating FP clients, especially in situations where providers feel they cannot trust women to answer questions honestly. Thus, family planning clinics will be provided with free pregnancy test strips, and the change in same day uptake of FP methods will be measured.
Hypotheses
- Providing family planning messages to women attending immunization clinics with their child will cause them to seek family planning services in a greater proportion at 9-12 postpartum.
- The availability of free pregnancy testing will increase same day method provision for new and restarting family planning clients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supply | Experimental | Other: Pregnancy TestIn each country, this arm will be comprised of women attending family planning clinics within the 5 facilities randomized to this group. |
| Demand | Experimental | Other: Job aidIn each country, this arm will be comprised of women attending immunization clinics within the 5 facilities randomized to this group. |
| Control | No intervention | –In each country, this arm will be comprised of women attending family planning and immunization clinics in 5 facilities randomized to this group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- New and restarting family planning client (women seeking family planning service)
- Women with children 9-12 months of age attending immunization services
Key exclusion criteria (1 listed)
- Attending immunization services with a child other than one's own
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 |
|---|---|---|
| Pregnancy TestFree pregnancy test strips will be supplied to family planning clinics | Other | Supply |
| Job aidA new job-aid will be given to immunization providers that will guide them in assessing a mother's risk for pregnancy (based on LAM criteria), and guide them in making family planning referrals, including when a woman should start to use a family planning method if she wants to prevent pregnancy. The providers in immunization clinics will be asked to make such an assessment each time a woman has her baby vaccinated. Additionally, in family planning clinics located in the same facilities as the immunization clinics, family planning providers will be trained to use and provided with the pregnancy checklist (see "links" for more information on the checklist) | Other | Demand |
Primary outcome
The difference in current use of a modern family method among women attending immunization clinics for a child 9 to 12 months old between arms 2 and 3 of the study.
Time frame: 13 months
The difference in immediate uptake of a modern family planning method (excluding condoms) among new and re-starting family planning clients between arms 1 and 3 of the study.
Time frame: 6 months
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 13 Apr 2025.
- Background: PubMed 10470704Stanback J, Qureshi Z, Sekadde-Kigondu C, Gonzalez B, Nutley T. Checklist for ruling out pregnancy among family-planning clients in primary care. Lancet. 1999 Aug 14;354(9178):566. doi: 10.1016/S0140-6736(99)01578-0.
- Derived from this study: PubMed 23570834Vance G, Janowitz B, Chen M, Boyer B, Kasonde P, Asare G, Kafulubiti B, Stanback J. Integrating family planning messages into immunization services: a cluster-randomized trial in Ghana and Zambia. Health Policy Plan. 2014 May;29(3):359-66. doi: 10.1093/heapol/czt022. Epub 2013 Apr 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnancy Test and Job aid in people with Postpartum Period, run by FHI 360 at 2 sites in 2 countries.
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 1 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 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana, Zambia. 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?
The difference in current use of a modern family method among women attending immunization clinics for a child 9 to 12 months old between arms 2 and 3 of the study. (time frame: 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949481, which also lists 2 linked publications.
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 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.