Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04521517
Other study ID # AddisAbabaU
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2020
Source Addis Ababa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 346
Est. completion date December 31, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Addis Ababa University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT00928538 - Nurse Family Partnership (NFP) Contraceptive Study Phase 4
Completed NCT03660514 - Jovenes Sanos: Preventing IPV and RC N/A
Completed NCT02866643 - Labor and Delivery Implant Insertion: A Randomized Controlled Trial Phase 3
Completed NCT05503992 - Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia N/A
Recruiting NCT04558229 - RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users Phase 4
Completed NCT03973593 - Evaluation of Dynamics of Contraceptive Use, Discontinuation and Method Switching in Migori and Kitui Counties, Kenya
Completed NCT02714231 - Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion Phase 4
Completed NCT02711358 - Indomethacin Use in Pain Relief During Intrauterine Device Insertion Phase 4
Completed NCT01593943 - Gender Equity-Focused, Male-Centered Family Planning for Rural India Phase 3
Completed NCT03106727 - Evaluating the Impact of a Community Health Worker Program in Neno, Malawi N/A
Completed NCT01288274 - Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia N/A
Completed NCT03534401 - Addressing Reproductive Coercion in HEalth Settings - Kenya N/A
Completed NCT03576157 - Kilkari Impact Evaluation N/A
Not yet recruiting NCT04970420 - Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks). N/A
Completed NCT01894126 - Mobile Phone Messaging to Improve Women's and Children's Health (Mobile WACh) in Kenya N/A
Completed NCT03490617 - Misoprostol Prior to IUD Insertion in Nullipara Phase 3
Completed NCT06320964 - The TARANG Intervention N/A
Completed NCT03135288 - Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives N/A
Completed NCT02633631 - Contraceptive Choice Center
Completed NCT06450756 - Effect of Male Involvement in Family Planning Education on Contraceptive Use N/A