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Evaluation of Enhanced Delivery and Newborn Kit

Primary Purpose

Perinatal Death

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Enhanced Delivery and Newborn kit
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perinatal Death focused on measuring perinatal mortality, delivery kit, Newborn kit, health services

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Pregnant women in the project sites living in the area till expected date of their delivery. Exclusion Criteria: The individuals who would not consent to participate in the study voluntarily.

Sites / Locations

  • Aga Khan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Provision of Enhanced Delivery and Newborn Kits (CMWs and LHW program will continue to function as usual)

Standard Delivery Kits alone (CMWs and LHW program will continue to function as usual)

Outcomes

Primary Outcome Measures

Perinatal mortality rate
"Perinatal mortality is an important outcome indicator for newborn care and directly mirrors the quality of prenatal, intra partum and newborn care"

Secondary Outcome Measures

Cause specific neonatal mortality
such as deaths related to omphalitis, birth asphyxia, prematurity, and sepsis.
Cause specific maternal mortality
such as deaths related to postpartum hemorrhage, puerperal sepsis, eclampsia, obstructed labor, unsafe abortion, and indirect causes (anemia, malaria)
Maternal morbidity
such as (including obstetric fistula, eclampsia, and obstetrical sepsis)

Full Information

First Posted
November 28, 2022
Last Updated
August 2, 2023
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT05640063
Brief Title
Evaluation of Enhanced Delivery and Newborn Kit
Official Title
Evaluation of the Impact of Enhanced Delivery and Newborn Kits as Compared to Standard Delivery Kits in the Flood Affected Districts of Sindh and Balochistan Provinces: A Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 LHW program.
Detailed Description
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: • To reduce the perinatal mortality in flood affected areas Secondary Objectives: To mobilize community for creation of demand for improved MNH services and practices through community mobilization. To increase knowledge of target audiences for pregnancy, delivery, postdelivery and newborn danger signs To increase clean deliveries at home through provision of enhanced delivery and newborn kits To improve newborn care practices To strengthen and improve the quality of maternal and newborn care at health facilities through referral linkages Methodology Study design Cluster randomized controlled trial. Study Site and Context The Study will be conducted in in the flood affected districts (Lasbella, Qamabr Shahdad Kot, Sanghar and Dadu) within the Umeed e Nau (UeN) project Balochistan & Sindh. The project is operational in these areas through field offices. Maternal, Newborn and Child Health (MNCH) focused interventions are already rolled out, including capacity building of health care providers at secondary level care public health facility and community level on MNCH services i.e., EmONC, IMNCI (Integrated Management of Newborn and Child illness) and IYCF (Infant and young child feeding). The project field teams include doctors, social mobilizers, and technical personnel for the implementation of activities in close liaison with department of health (DOH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Death
Keywords
perinatal mortality, delivery kit, Newborn kit, health services

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We are considering Union Council as a cluster. Clusters will be identified and matched on population size, socio-economic status (including structure, electricity, drinking water assets with HH density), birth/death rates, and number of functional LHWs and CMWs. Paired randomization will be done to allocate one group (intervention/control) to each cluster and all the LHWs in one union council will be assigned to one group to avoid any sort of contamination.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Provision of Enhanced Delivery and Newborn Kits (CMWs and LHW program will continue to function as usual)
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard Delivery Kits alone (CMWs and LHW program will continue to function as usual)
Intervention Type
Other
Intervention Name(s)
Enhanced Delivery and Newborn kit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perinatal mortality rate
Description
"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
Secondary Outcome Measure Information:
Title
Cause specific neonatal mortality
Description
such as deaths related to omphalitis, birth asphyxia, prematurity, and sepsis.
Time Frame
12 months
Title
Cause specific maternal mortality
Description
such as deaths related to postpartum hemorrhage, puerperal sepsis, eclampsia, obstructed labor, unsafe abortion, and indirect causes (anemia, malaria)
Time Frame
12 months
Title
Maternal morbidity
Description
such as (including obstetric fistula, eclampsia, and obstetrical sepsis)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women in the project sites living in the area till expected date of their delivery. Exclusion Criteria: The individuals who would not consent to participate in the study voluntarily.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zahid Memon, MPH
Phone
03085550859
Email
zahid.memon@aku.edu
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahid. A Memon
Phone
13085550859
Email
zahid.memon@aku.edu
First Name & Middle Initial & Last Name & Degree
Zahid Memon, MPH
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, PhD
First Name & Middle Initial & Last Name & Degree
Shah Muhammad, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Enhanced Delivery and Newborn Kit

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