Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
KMC PPD
Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial
3 other identifiers
interventional
1,908
1 country
1
Brief Summary
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are:
- Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting?
- Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting?
- What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting?
- What is the prevalence of paternal depression in a low resource setting?
- Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge? Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings. Participants (infants) will:
- At time of discharge from the NICU, when clinically stable, spend either \< 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge.
- Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression.
- Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 22, 2026
April 1, 2026
1.6 years
August 1, 2024
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Mothers with Postpartum Depression (PPD)
Score on Edinburgh Postnatal Depression Scale (EPDS) screening tool obtained by interview with mother. This screening tool is a 10-question tool validated for use among pregnant women in low resource countries. It can be used for screening of perinatal depression, beginning from antenatal period up to 6-8 weeks postnatal age. Each question is scored between 0-3, the highest cumulative score being 30. Cut-off score for mothers with suspected postpartum depression (PPD) will be 11. All mothers who screen 11+ will be categorized to have PPD, all mothers scoring below 11 will be categorized as negative for PPD.
8 weeks
Secondary Outcomes (30)
Percentage of Mothers with Postpartum Depression (PPD)
2 weeks, 6 months, 12 months
Hours spent practicing Kangaroo Mother Care (KMC) in the neonatal intensive care unit (NICU)
2 weeks
Hours spent practicing Kangaroo Mother Care (KMC) in the KMC Ward
2 weeks
Hours spent practicing Kangaroo Mother Care (KMC) at home
2 weeks, 8 weeks, 6 months, 12 months
Time of initiation of breastfeeding
2 weeks
- +25 more secondary outcomes
Study Arms (2)
Admission to Kangaroo Mother Care (KMC) ward for > 2 days after discharge from NICU
EXPERIMENTALFollowing discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for greater than 2 days for continued support.
Admission to Kangaroo Mother Care (KMC) ward for < 2 days after discharge from NICU
PLACEBO COMPARATORFollowing discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for less than 2 days for continued support.
Interventions
Admission to the kangaroo mother care (KMC) ward with continued support of kangaroo mother care, breastfeeding, and preterm infant care for less than 2 days prior to discharge home
Eligibility Criteria
You may qualify if:
- AIM #1-2 and #5
- Mothers to newborns who are:
- \) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (\>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 months
- AIM #3
- Parents (mothers and fathers) whose newborn has been enrolled in the study
- Trusted family member or friend of the mother whose newborns is enrolled into the study
- + years of age (mothers and fathers)
- + years of age (family members)
- AIM # 4:
- Fathers whose newborn has been enrolled into the study
- + years of age (father)
You may not qualify if:
- AIM #1-2 and #5
- Mothers who are on treatment for depression and/or anxiety
- Mothers who did not consent
- Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study
- AIM #3
- \) Family members of parents who do not consent to study participation
- AIM # 4:
- Fathers who are on treatment for depression and/or anxiety
- Fathers who did not provide informed consent
- Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- University of Zambiacollaborator
- University Teaching Hospital, Lusaka, Zambiacollaborator
- University of Cincinnaticollaborator
- Centre for Infectious Disease Research in Zambiacollaborator
Study Sites (1)
Women and Newborn Hospital - University Teaching Hospitals
Lusaka, 10101, Zambia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Manasyan, MD, MPH
Centre for Infectious Disease Research in Zambia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 1, 2024
First Posted
August 9, 2024
Study Start
December 1, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
September 30, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be made available beginning 12 months following publication of the primary study results and will remain available for up to 5 years after publication.
- Access Criteria
- Data will be available to qualified researchers who submit a scientifically sound research proposal consistent with the objectives of the original study and compliant with ethical standards. Access will require: 1. Approval by the study's Data Access Committee 2. Evidence of ethics approval from the requestor's institution 3. Execution of a Data Use Agreement 4. Agreement not to attempt participant re-identification 5. Compliance with applicable Zambian data protection regulations and institutional policies Data will be shared through a secure data transfer platform or controlled-access repository.
De-identified individual participant data underlying the results reported in the primary publication, including maternal, paternal, and infant demographic characteristics, baseline maternal and paternal psychosocial variables, validated postpartum depression assessment scores, randomized intervention allocation, follow-up maternal and paternal mental health outcomes, relevant neonatal clinical variables collected as part of the study, and neurodevelopmental screening data of the infant. All direct identifiers will be removed. Indirect identifiers will be coded or aggregated to minimize re-identification risk in accordance with ethical and regulatory requirements in Zambia.