Evaluation of Enhanced Delivery and Newborn Kit

Perinatal Death Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640063
• Other study ID #: 2022-0979-3131
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Aga Khan University
• Contact: Zahid Memon, MPH
• Phone: 03085550859
• Email: zahid.memon[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Perinatal Death

Intervention

Other:
• Enhanced Delivery and Newborn kit
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.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cause specific neonatal mortality	such as deaths related to omphalitis, birth asphyxia, prematurity, and sepsis.	12 months
Secondary	Cause specific maternal mortality	such as deaths related to postpartum hemorrhage, puerperal sepsis, eclampsia, obstructed labor, unsafe abortion, and indirect causes (anemia, malaria)	12 months
Secondary	Maternal morbidity	such as (including obstetric fistula, eclampsia, and obstetrical sepsis)	12 months