Suspended

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

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What is being tested

Continuum of support on breastfeeding.

Behavioral
Who is being recruted

Behavior

+ Breast Feeding

+ Feeding Behavior

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: July 2023
See protocol details

Summary

Principal SponsorHealth Services Academy, Islamabad, Pakistan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 6, 2023

Actual date on which the first participant was enrolled.

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

Official TitleAn Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial
NCT05951868
Principal SponsorHealth Services Academy, Islamabad, Pakistan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBreast FeedingFeeding Behavior

Criteria

6 inclusion criteria required to participate
Age >18years

Both nulliparous and multiparous

Is between 28-32 week gestation

Able to understand and communicate in Urdu/Punjabi

Show More Criteria

3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group 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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Dhok Gujra, PakistanOpen Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH) in Google Maps
SuspendedOne Study Center