Group Postpartum and Well-Child Care for Maternal and Infant Health

Официальное название

Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: baseline, 6 months, and 12 months postpartum]
• Infant immunization completion rate per national immunization schedule [Срок оценки: 6 months, and 12 months after birth]

Вторичные конечные точки (12)

• Number of participants using a family planning method [Срок оценки: baseline, 6 months and 12 months postpartum]
• Number of Participants who recall postnatal care content as measured by structured survey [Срок оценки: 6 and 12 months postpartum]
• Self-reported peer connectedness as measured by study survey [Срок оценки: 6 and 12 months postpartum]
• Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) [Срок оценки: baseline, 6 months and 12 months postpartum]
• Number of Participants Exclusively breastfeeding at 6 months after birth [Срок оценки: 6 months postpartum]
• Partner communication as measured by relationship quality survey [Срок оценки: baseline, 6 months, and 12 months postpartum]
• Maternal nutrition as measured by dietary diversity survey [Срок оценки: baseline, 6 months, and 12 months postpartum]
• Maternal anemia - hemoglobin level measured by point-of-care bloodspot test [Срок оценки: baseline and 12 months postpartum]
• Hypertension as measured by blood pressure assessment [Срок оценки: baseline, 6 months, and 12 months postpartum]
• Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7) [Срок оценки: baseline, 6 months, and 12 months postpartum]
• Maternal mortality as measured by clinic reporting [Срок оценки: 6 months and 12 months postpartum]
• Infant growth as measured by weight-for-age per growth standards [Срок оценки: baseline, 6 months, and 12 months after birth]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Malawi · 16 центров

• 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
• … и ещё 8 центров

Идентификаторы

NCT: NCT07414901 · IRB00492477 · R01NR021403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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