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.
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.
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 group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Provision of Enhanced Delivery and Newborn Kits (CMWs and LHW program will continue to function as usual) Receives: Other: Enhanced Delivery and Newborn kit |
| Control Arm | No intervention | Standard 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.
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)
Cause specific neonatal mortality
such as deaths related to omphalitis, birth asphyxia, prematurity, and sepsis.
Measured: 12 months
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
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.
- First posted7 Dec 2022
- Study start1 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05640063
- Acronym / sponsor ID
- 2022-0979-3131
- Conditions
- Perinatal Death
- Keywords
- perinatal mortality, delivery kit, Newborn kit, health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Enhanced Delivery and Newborn kitProvision of Enhanced Delivery and Newborn Kits (CMWs and LHW program will continue to function as usual) |
| Control Arm | No intervention | –Standard Delivery Kits alone (CMWs and LHW program will continue to function as usual) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women in the project sites living in the area till expected date of their delivery.
Key exclusion criteria (1 listed)
- The individuals who would not consent to participate in the study voluntarily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Delivery and Newborn kitUnder 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. | Other | Intervention Arm |
Primary outcome
Perinatal mortality rate
Time frame: 12 months
"Perinatal mortality is an important outcome indicator for newborn care and directly mirrors the quality of prenatal, intra partum and newborn care"
3 secondary outcomes
Cause specific neonatal mortality
Time frame: 12 months
Cause specific maternal mortality
Time frame: 12 months
Maternal morbidity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.