AzTrials
AzTrials

Perinatal DeathNCT05640063

Evaluation of Enhanced Delivery and Newborn Kit

A study testing Enhanced Delivery and Newborn kit in people with Perinatal Death, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Lady Health Worker (LHW)… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Perinatal Death
What is being tested?
Enhanced Delivery and Newborn kit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 sitePakistan
Study dates
1 Mar 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Aga Khan University

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

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 Pakistan A Cluster Randomized Trial

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).
Conditions
Perinatal Death
Being tested
Enhanced Delivery and Newborn kit
Keywords
perinatal mortality, delivery kit, Newborn kit, health services
Medical subject headings
Perinatal Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Delivery and Newborn kitOther

    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.

Study groups in NCT05640063
Study groupRoleWhat they receive
Intervention ArmExperimentalProvision of Enhanced Delivery and Newborn Kits (CMWs and LHW program will continue to function as usual)
Receives: Other: Enhanced Delivery and Newborn kit
Control ArmNo interventionStandard Delivery Kits alone (CMWs and LHW program will continue to function as usual)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: 12 months

Secondary outcomes (3)
  1. Cause specific neonatal mortality

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

    Measured: 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)

    Measured: 12 months

  3. Maternal morbidity

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start1 Mar 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
2,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05640063
Sponsor's protocol ID
2022-0979-3131
Status last verified
Aug 2026
First submitted
28 Nov 2022
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Delivery and Newborn kit in people with Perinatal Death, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perinatal mortality rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in