CClinicalTrials.gg
CompletedNCT05640063Updated Aug 26, 2026

Evaluation of Enhanced Delivery and Newborn Kit

An interventional study of Enhanced Delivery and Newborn kit in Perinatal Death, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Aga Khan University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
2,400
Allocation
Randomized
Sex
All
01

Study 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 Lady Health Worker (LHW) program.

Read the 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 (Qambar ShahdadKot,and Dadu) within the Umeed e Nau (UeN) project-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 (Emergency Obstetric and Newborn Care), 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).
02

Conditions studied

  • Perinatal Death

Browse trials for

Keywords

  • perinatal mortality
  • delivery kit
  • Newborn kit
  • health services
03

In context

Perinatal Death

85 studies on the registry are indexed under Perinatal Death; 20 are open to participants now.

This study's enrollment of 2,400 is above the median of 500 across 58 interventional studies indexed under Perinatal Death.

Browse Perinatal Death studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • The individuals who would not consent to participate in the study voluntarily.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,400 participants (actual)

Study arms

  • Experimental
    Intervention Arm

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

    Other: Enhanced Delivery and Newborn kit

  • No intervention
    Control Arm

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

Interventions

  • OtherEnhanced 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.

06

What researchers measure

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"

    Time frame: 12 months

Secondary outcomes

  1. Cause specific neonatal mortality

    such as deaths related to omphalitis, birth asphyxia, prematurity, and sepsis.

    Time frame: 12 months

  2. Cause specific maternal mortality

    such as deaths related to postpartum hemorrhage, puerperal sepsis, eclampsia, obstructed labor, unsafe abortion, and indirect causes (anemia, malaria)

    Time frame: 12 months

  3. Maternal morbidity

    such as (including obstetric fistula, eclampsia, and obstetrical sepsis)

    Time frame: 12 months

07

Study locations

1 site
  • Aga Khan University
    Karachi, Sindh 74800, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05640063
Lead sponsor
Aga Khan University
Responsible party
Dr Zulfiqar Ahmed Bhutta (Distinguish University Professor, Aga Khan University) — Principal investigator
First posted
Dec 7, 2022
Start date
Mar 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Aug 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion