Infant Health, Postpartum Health
Conditions
Brief summary
The proposed study will evaluate the effectiveness of an integrated group postpartum and well-child care model, compared to individual (usual) postnatal and well-child care, on maternal and child health outcomes. Results will provide clinical evidence for improved maternal and infant health care in the first year postpartum. The study will inform and provide lessons learned to advance maternal and infant health service delivery models in low resource settings.
Detailed description
A cluster randomized controlled trial design with mixed methods will be used to determine the impact and comparative effectiveness of group versus usual individual care with postpartum women and the women's infants in 16 clinics across Zomba District, Malawi. Data is collected at baseline, 6- and 12-months. Women are nested within the postpartum/well-child care group for the intervention. In the control arm, dyads will be grouped based on order of entry within each site. The first 10 dyads will form "group" 1, the second 10 dyads "group" 2, etc. The investigators will also explore the health and health-related social needs that arise in the 12 months after birth for both women and the women's infants through in-depth interviews as well as implementation barriers and facilitators for group postpartum and well-child care.
Interventions
BEHAVIORALGroup Care
Group care in the postpartum period brings the same group of 8-10 women and their infants, born within one month of one another, together for one year of integrated healthcare for the dyad. Sessions are co-facilitated by a midwife and HSA. Each session is 120 minutes: first 30-45 minutes consist of self-assessments (measuring infant's weight/length, taking own vital signs) and standard health assessments by a clinician; health concerns are identified/managed and referrals made if needed. Followed by 75-90 minutes of interactive health promotion, skills-building, and support activities. 6-visit model aligned with Malawian vaccine schedule: 6 weeks, 10 weeks, 14 weeks, 6 months, 9 months, and 12 months.
Sponsors
Johns Hopkins University
National Institute of Nursing Research (NINR)
University of Michigan
Kamuzu University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Aims 1\&2: * Women presenting for their 1-week postnatal care visit with their infant at a study site clinic. * Over age 15. * One infant is less than 4 weeks old. * Able to speak and understand Chichewa. * Adolescents 15-17 must bring parent/guardian for consent/assent. Infants included as part of mother-infant dyad. Aim 3: * Midwife or HSA serving as group care co-facilitator or key stakeholders in MoH/Zomba District/clinical administration * Able to speak Chichewa and/or English.
Exclusion criteria
Aim 1\&2 * Under age 15. * Serious physical or mental illness or marked cognitive impairment preventing informed consent. * Inability to participate in full intervention * Multiple infants (e.g. twins, triplets) Aim 3 -Serious physical or mental illness or marked cognitive impairment preventing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS) | baseline, 6 months, and 12 months postpartum | The EPDS is a 10-item self-report scale with scores ranging from 0-30; higher scores indicate more depressive symptoms. |
| Infant immunization completion rate per national immunization schedule | 6 months, and 12 months after birth | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants using a family planning method | baseline, 6 months and 12 months postpartum | — |
| Number of Participants who recall postnatal care content as measured by structured survey | 6 and 12 months postpartum | — |
| Self-reported peer connectedness as measured by study survey | 6 and 12 months postpartum | Peer connectedness assessed via a 14-item survey. Total score range: 0-56. Higher scores indicate greater peer connectedness. |
| Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) | baseline, 6 months and 12 months postpartum | The BSES-SF is a 14-item self-report scale with a total score range of 14-70. Higher scores indicate greater breastfeeding self-efficacy. |
| Number of Participants Exclusively breastfeeding at 6 months after birth | 6 months postpartum | — |
| Partner communication as measured by relationship quality survey | baseline, 6 months, and 12 months postpartum | 2-item survey with total score range 0-2. Higher scores indicate higher relationship quality. |
| Maternal nutrition as measured by dietary diversity survey | baseline, 6 months, and 12 months postpartum | Dietary diversity assessed via 6-item 24-hour recall with a total score range of 0-6. Higher scores indicate greater dietary diversity. |
| Maternal anemia - hemoglobin level measured by point-of-care bloodspot test | baseline and 12 months postpartum | — |
| Hypertension as measured by blood pressure assessment | baseline, 6 months, and 12 months postpartum | Hypertension assessed by systolic and diastolic blood pressure measurement in mmHg. Hypertension defined as systolic ≥140 mmHg and/or diastolic ≥90 mmHg per WHO guidelines. |
| Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7) | baseline, 6 months, and 12 months postpartum | Anxiety symptoms assessed using the GAD-7, a 7-item self-report scale with a total score range of 0-21. Higher scores indicate greater anxiety. |
| Maternal mortality as measured by clinic reporting | 6 months and 12 months postpartum | — |
| Infant growth as measured by weight-for-age per growth standards | baseline, 6 months, and 12 months after birth | — |
| Infant growth as measured by length-for-age per growth standards | baseline, 6 months, 12 months after birth | — |
| Infant nutritional status as measured by mid-upper arm circumference (MUAC) | 6 months and 12 months after birth | — |
| Infant anemia as measured by point-of-care hemoglobin bloodspot test | 12 months after birth | — |
| Child development as measured by the Malawi Developmental Assessment Tool (MDAT) | 6 months and 12 months after birth | Child development assessed using the MDAT, a tool measuring four domains: gross motor, fine motor, language, and social development. Each domain is scored 0-34 based on passed items. Total score range: 0-136. Higher scores indicate more advanced development. |
| Infant mortality as measured by clinic reporting and parent's self-report | 6 months and 12 months after birth | — |
Countries
Malawi
Contacts
CONTACTAshley Gresh
CONTACTEllen Chirwa
PRINCIPAL_INVESTIGATORAshley Gresh
Johns Hopkins University
Outcome results
None listed