Aga Khan University
Karachi, Sindh, 74800, Pakistan
NCT Number: NCT02412293
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.
Looking for future studies?
Notify Me14 year and older
All sexes
Interventional
Not applicable
Karachi, Sindh, 74800, Pakistan
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
Phase 1: Formative Research The objectives of this first phase of the study are as follows
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
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level.
Training of health workers on recognition of danger sign that warrant referral to health care service.
Community mobilization activities included formation of community health committees and creation of support for the uptake of the interventions.
Time frame: 3 years
Baseline & Endline Surveys
Time frame: 3 Years
Baseline & Endline Surveys
Time frame: 3 Years
Baseline & Endline Surveys
Time frame: 3 Years
Baseline & Endline Surveys
Time frame: 3 Years
Baseline & Endline Surveys
Time frame: 3 Years
Baseline & Endline Surveys
Aga Khan University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04279899
Communicable Diseases, Disease Attributes
Wuhan, Hubei, China
View Trial DetailsNCT06164080
Antenatal Corticosteroid, Perinatal Problems
Bursa, Turkey (Türkiye)
View Trial DetailsNCT05225376
Behavior, Morbidity;Perinatal
Clermont-Ferrand, France
View Trial DetailsNCT05429242
Female Urogenital Diseases and Pregnancy Complications, Maternal-Fetal Relations
Siirt, Turkey (Türkiye)
View Trial Details