Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05951868 |
| Other study ID # |
2226-HSA |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 6, 2023 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Health Services Academy, Islamabad, Pakistan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Malnutrition and non optimal breastfeeding is one the the major cause of high infant
morbidity and mortality in a developing country like Pakistan. In addition low women literacy
rate,socioeconomic factors, cultural limitations,poor excess to information, misconceptions
and other factors has led to low breastfeeding rates.
There has also been a shift over time from home based care and delivery to antenatal care
from skilled providers and deliveries within health care facilities. Which is an opportunity
to strengthen breastfeeding counselling to mothers starting from health facility where
mothers come for antenatal visits and by utilising other modes of counselling within the
health facility (which have weak or non-existing structured breast feeding program) and when
mothers home till 6 months as a continuous support. Women from different backgrounds have
opportunity to get excess to complete information on benefits,misconceptions and myths of
breastfeeding which is understandable and acceptable by her, to enable her to make an
informed decision to initiate early, exclusively breastfeed and to continue breastfeeding
till 2 years or beyond.
The intervention group will receive interventions, will include a family member as a support
for participant in her breastfeeding, 2 sessions of counselling on breastfeeding during
participants antenatal visits,sharing of readable booklet & video messages on Whats App
application of cell phones about breastfeeding, hands on training by nurse after delivery,
and continuum of support by multiple visits of lady health workers when the mothers home till
6 months. It will also include training of doctor,nurse & lady health workers involved in the
intervention.
The content of intervention will contain benefits & ideal breastfeeding practices, latching &
feeding positions,expression & storage of breast milk, associated myths & difficulties with
solutions in breastfeeding.
The control group participants will receive the routine support on breastfeeding given in
hospital and in the community.
Feasibility, acceptability, cost effectiveness, sustainability and effectiveness of the
intervention will be assessed.
Description:
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
