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An Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial

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Qué se está evaluando

Continuum of support on breastfeeding.

Conductual
Quiénes están siendo reclutados

A partir de 18 años
+9 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: julio de 2023
Ver detalles del protocolo

Resumen

Patrocinador PrincipalHealth Services Academy, Islamabad, Pakistan
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 6 de julio de 2023

Fecha en la que se inscribió al primer participante.

Feeding of Infant and young child is a fundamental area to enhance child survival and promote its growth and development As per World Health Organisation (WHO) current global health observatory's data on developing country Pakistan, infant mortality of 53 per 1000 live births and under 5 mortality rate of 63 per 1000 live births is significantly due to malnutrition and non-optimal breast feeding practices. With a shift to 86% women receiving Antenatal care from a skilled provider, 66% deliveries at health facilities, 69% births attended by skilled providers and 81% percent of births to urban mothers in a health facility.. Also keeping in mind literacy rates, socioeconomic factors, cultural limitations, skills of care providers, limited resource settings, local context, knowledge of mothers on breastfeeding and myths related to breastfeeding, it's an opportunity to initiate and strengthen a continuum of support breastfeeding program starting from hospitals (which have weak or non-existing structured breast feeding program) and extending to community when mothers are at home. In continuum of care program with multi component support interventions starting from antenatal period till 6 months postpartum need to be tested for its feasibility, acceptability, cost effectiveness, sustainability and effectiveness to improve exclusive breast feeding and timely weaning and continued breastfeeding until 2 years or beyond. After recruitment of 50 women coming for their antenatal checkup as per inclusion/exclusion criteria and by informed consent. Demographic data will be collected and they will be randomly allocated into intervention and control groups. Care providers involved in the intervention will be trained by a training session. Intervention group Participants will be invited on next antenatal visits in the health facility; 1. Participants will be accompanied by a female family member of her choice considered as her support ( to encourage and assist mother at home on exclusively breast feeding and continuation of breastfeeding ) 2. Participants will be counselled in groups of 5 to 7 in 2 sessions for 45- 60 minutes on benefits \& ideal breastfeeding practices, latching \& feeding positions, associated myths \& difficulties in breastfeeding, discussion and question answer session by a trained doctor in presence of a family member 3. To read Booklet will be given to participants and video recordings having same content as counselling session will be sent by Whats App during antenatal visits and at discharge. 4. At the time of delivery nurse will assist in skin to skin contact, early initiation, proper latching train on feeding positions and reemphasise on exclusive breast feeding. After delivery and discharge of participant mother from hospital; 1\. Trained Lady Health workers (LHWs) of the participant's catchment area will visit at 0,1,2 weeks 1,3,4 \& 6 months to reemphasise and support on already learned ideal breastfeeding practices. The control group participants will receive the routine support on breastfeeding given in hospital and in the community. Primary \& Secondary Outcomes will be measured by a semi structured questionnaire on telephonic call to participants

Título OficialAn Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial
NCT05951868
Patrocinador PrincipalHealth Services Academy, Islamabad, Pakistan
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 50 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

6 criterios de inclusión requeridos para participar
Age >18years

Both nulliparous and multiparous

Is between 28-32 week gestation

Able to understand and communicate in Urdu/Punjabi

Mostrar Más Criterios

3 criterios de exclusión impiden participar
Lady Health Worker currently not present in mothers catchment area.

Not able to communicate verbally due to any reason.

Known medical conditions, congenital malformations or mental illness that may hinder in breastfeeding.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Content of counselling intervention will be on ideal breast feeding practices,benefits of breastfeeding, weaning, myths \& common problems faced during breastfeeding with their solutions,Latching techniques,feeding positions, ways to express milk \& storage techniques. Discussion and Q\&A session 1. Women with her female family member of support invited for antenatal visit will be counselled by a trained doctor on breastfeeding in 2 -sessions between 32 \& 40 weeks of gestation. 2. Readable booklet \& whats app videos having same content in local Urdu language will be shared with the women during antenatal visit and at discharge from hospital. 3. At time of delivery skin to skin contact, early initiation, proper latching ,positioning and reemphasising on exclusive breastfeeding done by a trained nurse. 4. Follow up by trained community lady health workers to visit mothers home to reinforce learned information and support mothers at 0,1,2 weeks \& 1,3,4,6 months

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH)

Dhok Gujra, PakistanAbrir Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH) en Google Maps
Suspendido1 Centros de Estudio