Perinatal Problems Clinical Trial
Official title:
Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration
There is limited evidence from community-based interventions to guide the development of
effective maternal, perinatal and newborn care practices and services in developing
countries. Investigators planned to evaluate the impact of a low-cost package of
community-based interventions implemented through government sector lady health workers
(LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on
perinatal and neonatal outcomes in a sub-population of the remote mountainous district of
Gilgit, Northern Pakistan.
A community-based package for use by LHWs and CHWs geared towards prevention and promotion
of maternal and newborn health practices and services will be developed based on formative
research in the study district. The package will include promotion of antenatal care,
adequate nutrition, skilled delivery and healthy newborn care practices at household level.
The health workers will be trained in recognition of danger sign that warrant referral to
health care service. LHWs and CHWs will delivered the package via community awareness
sessions and two one-to-one counselling sessions to pregnant women during third trimester
and five newborn assessment visits in the neonatal period. In addition to this, community
mobilization activities included formation of CHCs and creation of support for the uptake of
the interventions. Control areas will continue to receive the routine standard health
services of governmental and non-governmental organizations in the area. The intervention
areas will receive the intervention package in addition to the routine standard health
services. Outcome measures will include changes in maternal and newborn-care practices and
perinatal and neonatal mortality rates between the intervention and control areas.
The World Health Organization estimates that globally over 9 million infants die annually
before birth or in the first few weeks of life, and that the majority of these deaths occur
in the neonatal period. The bulk of these deaths result from pregnancy or delivery
associated complications, premature births, intrauterine growth retardation and infectious
diseases.
There are over seven million perinatal deaths annually globally mostly in developing
countries. Almost 4 million newborns suffer moderate to severe birth asphyxia, with at least
800,000 dying and probably a higher number developing sequel such as epilepsy, mental
retardation, cerebral palsy and learning disabilities. A recent community based study in
Zimbabwe, which audited perinatal mortality showed the commonest single cause was perinatal
asphyxia and an avoidable factor was detected in 76% of cases. In another population based
study in Bangladesh, which showed a perinatal mortality rate of 75 per 1000 births (37
stillbirths, 38 first week deaths), the major causes of early neonatal death were attributed
to a small size at birth (54%), birth asphyxia (26%), and tetanus (8%). In Bangalore, South
India a prospective hospital based study of 4572 births showed a perinatal mortality of
43/1000. Using the Wiggles worth's classification , 24% were considered due to birth
asphyxia, even after exclusion of the premature group. Similarly a recent evaluation of a
large hospital-based birth cohort for perinatal deaths in Karachi according to the Wiggles
worth's criteria, indicated that almost 30% of all deaths were related to acute asphyxia.
Hypotheses
1. A concerted and coordinated community-based program of training first level primary
care workers i.e. TBAs, LHWs, lady health visitors and rural health center physicians
in the prevention, early recognition and management of common perinatal / neonatal
problems will result in a significant reduction in perinatal and neonatal mortality in
the Northern areas of Pakistan.
2. A coordinated program of community education and awareness in the importance of
perinatal care, prevention and recognition of neonatal problems will lead to improved
neonatal health, better recognition of neonatal problems and care-seeking behavior.
3. The strengthening of secondary care perinatal and newborn care and reproductive health
services will lead to improved referral patterns for perinatal / neonatal problems with
better outcome.
4. Increasing the community awareness of neonatal problems and training of first level
primary care workers will result in better domiciliary management of neonatal problems.
Phase 1: Formative Research The objectives of this first phase of the study are as follows
1. Determination of preconditions for studying care seeking practices (referral system,
availability of BHU staff, doctors, LHVs)
2. Focusing questions for formative research on care-seeking and causes of perinatal /
neonatal morbidity / mortality by a modified perinatal / neonatal verbal autopsy)
3. Rapid anthropological assessment of care-seeking behavior
4. Illness Episode and Channel Survey
5. Analysis of results of formative research
6. Identification of desired behaviors and changes
7. Selection of behaviors for intervention and their potential acceptability
8. Acceptability of planned intervention(s) for families, communities and care providers
and possible additional structural changes
This initial phase of formative research, will be conducted in the
Hunza-Karimabad/Nagar/Gojal tehsils of the Gilgit District of the Northern areas. A combined
methodology of KAP survey and verbal/social autopsy will be employed. These will include an
in-depth evaluation of knowledge, attitude and practices of families and primary care givers
(TBAs, LHWs, LHVs and BHU/RHC staff) with regards to
- Common causes of maternal morbidity in pregnancy
- Maternal nutrition and dietary patterns in pregnancy
- Determinants of care seeking behavior during pregnancy and labor
- Domiciliary versus hospital births
- Selection of care givers by families
- Reasons for referral by primary care givers
- Perception and recognition of danger signs during child birth by families and care
givers
- Immediate and early newborn care practices (colostrum and prelacteal feeding,
breastfeeding, cord care, temperature regulation, swaddling, skin care etc).
- Concepts of early neonatal morbidity and health seeking behavior;
- Risk factors for birth asphyxia and meconium aspiration
- Low birth weight and temperature regulation
- Neonatal infection (local and generalized)
- Seizures or spasms
- Respiratory problems
- Jaundice
- Feeding difficulty
Phase 2: Implementation phase
The overall objectives of this phase of the intervention are introduction and implementation
of simple education and training materials for families and caregivers for community-based
perinatal and newborn care by means of a phased introduction of the program in the area. In
addition primary care givers in the target villages of the study area would receive training
in stabilization and early referral of sick newborns for secondary care.
The intervention package, consisting of awareness creation about positive maternal and
newborn health care practices at household level such as importance of; seeking antenatal
care, adequate nutrition during pregnancy and lactation, skilled birth attendance, early
initiation of breastfeeding, delayed bathing recognition of danger signs that warrant for
early referrals, will be developed in collaboration with the Aga Khan Health Services,
Pakistan. The practices will promote though community mobilization and education strategy
that included formation of Community Health Committee (CHC) and group education sessions
using flip charts and videos.
The LHWs and CHWs in the intervention areas will provide with enhanced trainings on causes
of perinatal and newborn mortality and risky maternal and newborn care practices and
expecting to transmit the knowledge to the families to avoid such practices. They will
receive training in delivering the intervention package through standardized workshops
including hands on practice on use of specific Information Education and Communication (IEC)
materials developed for this purpose. The recently modified and simplified integrated
management of neonatal and childhood illnesses (IMNCI) based system formed the basis of
screening, recognition of danger signs and referral. The CHWs will deliver interventions in
LHW uncovered areas within the intervention areas.
Control areas will continue to receive the routine services of governmental and
non-governmental organizations in the area. But the public health care facilities of both
intervention and control areas will receive similar competency based trainings in
stabilization and early referral of sick newborns for secondary care.
The intervention Package The LHWs and CHWs will receive trainings on IMNCI-based training
package. They will also receive orientation about the purpose of the project and how can
they facilitate group education session by using flip charts and videos. The community-based
health education sessions will be introduced targeting local communities to sensitize them
regarding maternal, perinatal and newborn health issues.
In addition to this, Two days training workshops will be organized to train TBAs in
intervention areas on "Clean Delivery Practices" at nearest health facilities. The UNICEF
manual of (DAI) training will be adopted for this training.
The intervention package will be delivered through monthly household visits, one-to-one
counseling sessions with pregnant women and video sessions in communities. Additionally,
LHWs and CHWs in the intervention areas will record information about home visits, newborn
illnesses, referrals, live births and deaths on special format designed for this project.
For community mobilization and education, two types of tools will be used one group session
by use of flip charts and group session by use of video. Participants will be invited from
all Muhallas (Sub-geographical distribution of the village population) to attend the
session, facilitated by LHW/CHW to organize the session. Separate sessions will be organized
for males and females. One session per area will be organized on quarterly basis in local
school or LHW health house or CHW household within intervention areas. Target groups will be
women of reproductive age, adolescent girls, fathers, mothers and fathers in law and mothers
in law.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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