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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Ghana1 site
  • Central Region, GHANA

    Cape Coast, Central Region

Other trials in Ghana

Zambia1 site
  • Central Province, ZAMBIA

    Kabwe;Chibombo, Central Province

Other trials in Zambia

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.

  1. 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.
  2. 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

  1. 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.
  2. The availability of free pregnancy testing will increase same day method provision for new and restarting family planning clients.
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 groups in NCT00949481
Study groupRoleWhat they receive
SupplyExperimentalIn 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
DemandExperimentalIn each country, this arm will be comprised of women attending immunization clinics within the 5 facilities randomized to this group.
Receives: Other: Job aid
ControlNo interventionIn 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.

  1. 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

  2. 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.

  1. First posted30 Jul 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

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)
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 10470704
  • Vance 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

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.

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