Aga Khan University
Karachi, Sindh, 74800, Pakistan
NCT Number: NCT05640063
The evidence is required to assess the effectiveness of enhanced delivery and newborn kits as compared to standard delivery kits in the flood affected districts that can increase the utilization of services and reduce the delays that are responsible for poor maternal and newborn health through Lady Health Worker (LHW) program.
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Interventional
Not applicable
Karachi, Sindh, 74800, Pakistan
Addressing birth-related deaths is especially important since they frequently result from problems during childbirth, creating emergency situations with a limited window of opportunity for intervention (1).Globally, 2.4 million newborns die each year with one million of these neonatal deaths in the first week of life and 1.2 million stillborn neonates are caused by maternal health complications, indicating a significant intervention gap exists throughout pregnancy, childbirth, and the early postpartum period, when mothers and babies are most at risk (2). The major cause of maternal mortality is obstetric hemorrhage, puerperal sepsis, and hypertensive disorders in pregnancy. Anemia and malaria are the commonest indirect cause of maternal morbidity and mortality (3). Among newborn deaths sepsis is the leading cause followed by birth asphyxia and low birth weight. These complications compounded by unhygienic delivery practices such as lack of cord care, with no proper handwashing and improper waste disposal at home and at facility (4).
Though, there are many variables that contribute to maternal and neonatal fatalities, one of the most efficient ways to address this issue is to quickly provide mothers and newborns with effective preventive measures or treatment, frequently at home or at first level healthcare platform (5; 6).
Recent rains and floods also have damaged not only the health care facilities but access to these facilities is a challenge (10). In times of crisis, the capacity of health facilities, including skilled birth attendants and emergency obstetric care is often unavailable, which increases women's vulnerability. Complications that occur during pregnancy or childbirth are a leading cause of death and illness among women and young girls in the affected areas. According to the United Nations Population Fund, more than 650,000 pregnant women in flood affected areas require urgent maternal health services, with at least 73,000 women expected to give birth. (11).Hypothesis We hypothesize that provision of the Enhanced delivery and newborn kits will reduce the Perinatal mortality as compared to standard delivery kits Operational Definition of Perinatal Mortality "Perinatal mortality is an important outcome indicator for newborn care and directly mirrors the quality of prenatal, intra partum and newborn care" (18).
The specific objectives of this study are
Primary Objective:
Secondary Objectives:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Under this study enhanced delivery and newborn kits will be provided to the identified pregnant women to utilize at home or at health facility and avoid delays at facility. After the training of community and health care providers, the intervention package will be delivered in the intervention clusters primarily through the LHWs and CMWs.
Time frame: 12 months
"Perinatal mortality is an important outcome indicator for newborn care and directly mirrors the quality of prenatal, intra partum and newborn care"
Time frame: 12 months
such as deaths related to omphalitis, birth asphyxia, prematurity, and sepsis.
Time frame: 12 months
such as deaths related to postpartum hemorrhage, puerperal sepsis, eclampsia, obstructed labor, unsafe abortion, and indirect causes (anemia, malaria)
Time frame: 12 months
such as (including obstetric fistula, eclampsia, and obstetrical sepsis)
Aga Khan University
Other
Evaluation of the Impact of Enhanced Delivery and Newborn Kits as Compared to Standard Delivery Kits in the Flood Affected Districts of Sindh Pakistan A Cluster Randomized Trial
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