Family PlanningNCT04521517
Effect of Pamphlet Supported Counseling During Child Immunization on the Initiation of Post-partum Family Planning
A study testing pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning in people with Family Planning, run by Addis Ababa University.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning
- What is being tested?
- pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 31 Dec 2021
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Addis Ababa University
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.
Read the 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.
- Conditions
- Family Planning
- Being tested
- pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning
- Keywords
- Postpartum, Family Planning, Intervention, Pamphlet, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planningBehavioural
a pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning
| Study group | Role | What they receive |
|---|---|---|
| Pamphlet with timing of family planning | Experimental | Pamphlet with timing of family planning" and "Routine service" Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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.
Measured: Time since birth to the 9th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start15 Sep 2020 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Sawra Getnet, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521517
- Sponsor's protocol ID
- AddisAbabaU
- Status last verified
- Feb 2020
- First submitted
- 17 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38766567
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addis Ababa University
- ClinicalTrials.gov ID
- NCT04521517
- Acronym / sponsor ID
- AddisAbabaU
- Conditions
- Family Planning
- Keywords
- Postpartum, Family Planning, Intervention, Pamphlet, Ethiopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pamphlet with timing of family planning | Experimental | Behavioral: pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planningPamphlet with timing of family planning" and "Routine service" |
| Only routine service | No intervention | –Receive only routine service |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planninga pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning | Behavioural | Pamphlet with timing of family planning |
Primary outcome
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]
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Derived from this study: PubMed 38766567Gelaw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning in people with Family Planning, run by Addis Ababa University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Family planning utilization (time frame: Time since birth to the 9th 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 NCT04521517, which also lists 1 linked publication.
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 21 Aug 2020.