- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521517
Effect of Pamphlet Supported Counseling During Child Immunization on the Initiation of Post-partum Family Planning
Addis Ababa University
Study Overview
Status
Conditions
Detailed Description
Evidence shows that family planning is a cost-effective public health intervention with the potential to reduce both maternal and child mortality. However, around 222 million women have an unmet need for family planning, with the majority of these women living in low- and middle-income countries. There were 213 million pregnancies in 2012, most of which ended in birth. This number will certainly increase as the global population continues to grow, and a large proportion of youth enter their childbearing years. Regardless of whether the growing number of births are intended or unintended, they indicate an immense opportunity to reach postpartum women with family planning for spacing subsequent pregnancies. Citing the prospective definition of unmet need for family planning, which uses a postpartum woman's fertility preferences looking forward at the time of the survey, as many as 50%-90% of women from 17 low- and middle-income countries (LMICs) report an unmet need for postpartum family planning (PPFP).
Women frequently return to fertility and sex before initiating contraception after delivery and do not necessarily understand the risk of pregnancy before the return of menses. For instance, a report on Demographic and Health Survey (DHS) data showing that in Bangladesh, 33% of women resumed sexual activity within 3 months postpartum, but only 7.2% were using contraception. In Rwanda, these proportions are 73.6% and 1.7%, respectively. In all 17 countries analyzed, women were more likely to use contraception after menses returned than it was before. Therefore, family planning is critical for saving the lives of women and children in the developing world.
The World Health Organization (WHO) recommends postpartum family planning as a critical component of health care that has the potential to meet women's desire for contraception and save millions of maternal and infant lives in low- and middle-income countries.
This review aims to answer the research question: what recent interventions in LMIC have led to improvements in postpartum family planning outcomes? Therefore, the purpose of this review is to add to the existing body of evidence by casting a wide net in an attempt to capture the recent intervention strategies that present the most promise for decreasing the unmet need for contraception among postpartum women living in low- and middle-income countries (those defined as "developing" by the World Bank). The postpartum period is defined here as the 12 months after delivery. The study will assess the effectiveness of postpartum family planning (PPFP) interventions on clients' contraceptive knowledge, intention, and postpartum family planning use.
The rationale for the promotion of family planning to delay conception after a recent birth is a best practice that can lead to optimal maternal and child health outcomes. Despite the above fact uptake of postpartum family planning remains low in sub-Saharan Africa.
Therefore, the study through the use of an intervention having thorough counseling supplemented by pamphlets that will improve the awareness of women on modern use of family planning methods will improve their unmet need for family planning during postpartum time as a potential to contribute to achieving the Ethiopian Health Sector Transformation Plan and the Sustainable Development Goals. This study will help to understand the potential barriers and facilitators of PPFP uptake and the findings will be useful in modifying practice among the health care workers providing care at the maternal, neonatal, and child health (MNCH) clinics. This will create as an opportunity for the health providers and policymakers to learn to address the health needs of a community (they are working in) through a scholarly activity which is one of the family planning competencies and could be directly involved in the intervention plan to improve the gaps identified by working closer to the community.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women above the age of 18 and who are able to consent,
- Attending their child's 1st day, 6th-week or 10th-week vaccination,
- Apparently healthy, willing to continue child vaccination in the health center
Exclusion Criteria:
- Women who already started the use of contraception during the recruitment time
- Women who did permanent sterilization by hysterectomy or bilateral oophorectomy
- Women who are not the biological mother of the index child for vaccination
- Women who don't have either personal or home phone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pamphlet with timing of family planning
Pamphlet with timing of family planning" and "Routine service"
|
a pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning
|
No Intervention: Only routine service
Receive only routine service
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family planning utilization
Time Frame: Time since birth to the 9th months
|
Women will be assessed for utilization of modern family planning within nine months of delivering the index child [from interview and record reviewing]
|
Time since birth to the 9th months
|
The median time of family planning use
Time Frame: Time since birth to the 9th months
|
Women will be assessed the time of initiation of family planning [from interview and record reviewing] and will be computed in weeks since the birth of the child.
|
Time since birth to the 9th months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AddisAbabaU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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