Evaluation of Enhanced Delivery and Newborn Kit

NCT05640063 | Unknown DMC

• 1 other identifier: 2022-0979-3131
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Death

Keywords

perinatal mortality; delivery kit; Newborn kit; health services

Outcome Measures

Primary Outcomes (1)

• 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"

  12 months

Secondary Outcomes (3)

• Cause specific neonatal mortality

  12 months

• Cause specific maternal mortality

  12 months

• Maternal morbidity

  12 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Other: Enhanced Delivery and Newborn kit

Control Arm

NO INTERVENTION

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

Interventions

Enhanced Delivery and Newborn kit OTHER

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.

Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women in the project sites living in the area till expected date of their delivery.

You may not qualify if:

• The individuals who would not consent to participate in the study voluntarily.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zahid Memon, MPH

CONTACT

03085550859; zahid.memon@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguish University Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)