Effect of Pamphlet Supported Counseling During Child Immunization on the Initiation of Post-partum Family Planning

NCT04521517 | Unknown

• 1 other identifier: AddisAbabaU
• Study Type: interventional
• Target: 346
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background:- 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. Family planning is known to avert a higher number of maternal deaths and child mortality. Closely spaced pregnancies within the first year postpartum are the riskiest for the mother and baby, resulting in increased risks for adverse outcomes, such as preterm, low birth weight, and small for gestational age. Adding the existing body of evidence use of intervention strategies that promote and increase postpartum family planning in the developing world is important. Therefore, this study aims to evaluate the effect of the use of pamphlet supported by counseling during child immunization in improving the overall and average time of initiation of postpartum family planning utilization in the first nine months after delivery and assess its socio-demographic predictors in selected health centers of Addis Ababa, Ethiopia Methods:- The study will use implementation science with a randomized control trial study design. The study will involve mothers coming for vaccination of their newborn child to selected three health centers that are under the catchment area of Tikur Anbessa Teaching Hospital, in Addis Ababa. Eligible mothers will be randomly assigned into intervention and non-intervention arms using computerized assignments assisted by an envelope. Mothers assigned to the interventional arm will be given a pamphlet that advises mothers about postpartum family planning followed by counseling service while women in the non-intervention arm will take the routine immunization service given in the health services. Both groups will be followed until the 9th month after the birth of the child. In the 9th month after the birth of the child, during child vaccination for measles, women will be asked for the starting date the first family planning service. A comparison of family planning service will be made between the groups using logistic regression, using bivariate and multivariable analysis. The study also will use Kaplan Meier and Cox-regression to compare the median time of postpartum family planning and its correlation using SPSS for windows version 26. The research will undertake from Dec 2019 to June 2021.

Conditions

Family Planning

Keywords

Postpartum; Family Planning; Intervention; Pamphlet; Ethiopia

Outcome Measures

Primary Outcomes (2)

• Family planning utilization

  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

  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

Study Arms (2)

Pamphlet with timing of family planning

EXPERIMENTAL

Pamphlet with timing of family planning" and "Routine service"

Behavioral: pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning

Only routine service

NO INTERVENTION

Receive only routine service

Interventions

pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning BEHAVIORAL

a pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning

Pamphlet with timing of family planning

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addis Ababa University: lead

Related Publications (1)

• Gelaw SG, Deyessa N, Kidane A, Evensen A, Teka A, Bokan B, Yesuf SA. Effect of postpartum family planning intervention and associated factors during child immunization in Addis Ababa, Ethiopia. Pan Afr Med J. 2024 Mar 6;47:110. doi: 10.11604/pamj.2024.47.110.34883. eCollection 2024.

  PMID: 38766567 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Family Medicine

Model Details: The study will use implementation science, evaluated using a randomized control trial involving mothers coming for day 1, 6week and 10th-week vaccination of their neonate in the selected health centers, by allocating mothers randomly in two arms (the intervention and non-intervention). Mothers in the intervention arm will get thorough counseling on post-partum Family planning, will be provided with FP pamphlets in addition to the routine immunization service, while mothers from the control arms will get the routine immunization service for their babies.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: September 15, 2020
• Primary Completion: August 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 21, 2020

Record last verified: 2020-02