NCT00949481

Brief 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 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. 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.
  2. 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.
  3. 3.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.
  4. 4.The availability of free pregnancy testing will increase same day method provision for new and restarting family planning clients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

July 28, 2009

Last Update Submit

April 10, 2025

Conditions

Keywords

postpartumfamily planningjob aidimmunizationpregnancy test

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 months

Study Arms (3)

Supply

EXPERIMENTAL

In each country, this arm will be comprised of women attending family planning clinics within the 5 facilities randomized to this group.

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.

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.

Interventions

Free pregnancy test strips will be supplied to family planning clinics

Supply
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)

Demand

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • New and restarting family planning client (women seeking family planning service)
  • Women with children 9-12 months of age attending immunization services

You may not qualify if:

  • Attending immunization services with a child other than one's own

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Region, GHANA

Cape Coast, Central Region, Ghana

Location

Central Province, ZAMBIA

Kabwe;Chibombo, Central Province, Zambia

Location

Related Publications (2)

  • 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.

    PMID: 10470704BACKGROUND
  • 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.

MeSH Terms

Interventions

Pregnancy Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and GynecologicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 30, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 13, 2025

Record last verified: 2025-04

Locations