Group Postpartum and Well-Child Care for Maternal and Infant Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group Care.
- Who it may be relevant to
- Registry conditions: Postpartum Health, Infant Health. Basic parameters: 1 Week — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes
Overview
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
- Behavioral Group 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. Followe
Primary outcome measures
- Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS) [Time frame: baseline, 6 months, and 12 months postpartum]
- Infant immunization completion rate per national immunization schedule [Time frame: 6 months, and 12 months after birth]
Secondary outcome measures (12)
- Number of participants using a family planning method [Time frame: baseline, 6 months and 12 months postpartum]
- Number of Participants who recall postnatal care content as measured by structured survey [Time frame: 6 and 12 months postpartum]
- Self-reported peer connectedness as measured by study survey [Time frame: 6 and 12 months postpartum]
- Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) [Time frame: baseline, 6 months and 12 months postpartum]
- Number of Participants Exclusively breastfeeding at 6 months after birth [Time frame: 6 months postpartum]
- Partner communication as measured by relationship quality survey [Time frame: baseline, 6 months, and 12 months postpartum]
- Maternal nutrition as measured by dietary diversity survey [Time frame: baseline, 6 months, and 12 months postpartum]
- Maternal anemia - hemoglobin level measured by point-of-care bloodspot test [Time frame: baseline and 12 months postpartum]
- Hypertension as measured by blood pressure assessment [Time frame: baseline, 6 months, and 12 months postpartum]
- Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7) [Time frame: baseline, 6 months, and 12 months postpartum]
- Maternal mortality as measured by clinic reporting [Time frame: 6 months and 12 months postpartum]
- Infant growth as measured by weight-for-age per growth standards [Time frame: baseline, 6 months, and 12 months after birth]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Malawi · 16 centers
- Bimbi HC — Zomba
- Chamba HC — Zomba
- Chingale HC — Zomba
- Domasi HC — Zomba
- Lambulira HC — Zomba
- Likangala HC — Zomba
- M'mambo HC — Zomba
- Machinjiri HC — Zomba
- … and 8 more centers
Identifiers
NCT: NCT07414901 · IRB00492477 · R01NR021403