Antepartum HemorrhageSRCNCT02797353
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
A study testing Maternal Neonatal and Child Health Interventions in people with Antepartum Hemorrhage and Postpartum Hemorrhage, run by Aga Khan University.
Trial summary
The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected. Read more about this study
- Who is it for?
- Ages 1 day to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Antepartum Hemorrhage, Postpartum Hemorrhage, Anemia
- What is being tested?
- Maternal Neonatal and Child Health Interventions
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Aug 2016
- 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 1 day to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be a resident of target areas and consent to participate in the study
Who cannot join
- Do not fulfill the residence and consent criteria
About this study
The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected. Aga Khan University Pakistan is intending to implement a service delivery project for the improvement of Maternal Neonatal and Child health situation through evidence based MNCH interventions.
Read the detailed description
The Aga Khan University is implementing together with its local partners a MNCH project in five Union Councils (UC) in Dadu District in Sindh Province. The project will scale up the already existing health services for MNCH in the district referral hospital and the five Basic Health Units (BHUs), one in each UC. Institutional based services as well as their scope for outreach to pregnant women, mothers and children in the communities with the aim to promote safe deliveries as per WHO guidelines and Government policy will be enhanced. In order to deliver quality services, the facilities will be renovated and equipped and the capacity of the existing staff will be strengthened through different training courses in MNCH. In addition professionally trained Lady Health Visitors will be introduced in the BHUs, who will conduct all maternal services including deliveries in the BHU and the communities. The health staff is furthermore responsible to establish and facilitate community support groups and raise communal awareness for the importance of mother and child health care as well as safe deliveries with skilled attendants. Operational research is an integral part of this pilot project. The research validates the progress and improvement of maternal and child health indicators. The results will be used to lobby the scale up of MNCH interventions with the Ministry of Health in Pakistan.
- Conditions
- Antepartum Hemorrhage, Postpartum Hemorrhage, Anemia, Eclampsia, Neonatal Sepsis, Birth Asphyxia
- Being tested
- Maternal Neonatal and Child Health Interventions
- Medical subject headings
- Postpartum Hemorrhage, Anemia, Eclampsia, Neonatal Sepsis, Asphyxia Neonatorum, Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Neonatal and Child Health InterventionsOther
Antenatal care, postnatal care, skilled birth attendance, recognition and referral of complicated cases, immunization
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Antenatal Care, Post natal care, Skilled birth attendance, recognition and referrals of complicated cases, immunization Receives: Other: Maternal Neonatal and Child Health Interventions |
| Control | No intervention | This arm will receive the standard MNCH services as outlined in the MNCH policy of Government of Pakistan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal, Neonatal and infant mortality
A 20% reduction in mortality rates is expected
Measured: 24 months
Secondary outcomes (4)
Antenatal Care
A 40% Increase in Antenatal care is expected
Measured: 12 months
Skilled Birth attendance
A 40% increase in Skilled Birth attendance is expected
Measured: 12 months
Essential Neonatal Care
A 40% increase in uptake of Essential Neonatal Care
Measured: 24 months
Child hood Immunization Rates
A 30% increase in child hood immunization rates
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antepartum HemorrhageStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The International Federation of Red Cross and Red Crescent Societies
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Sajid Soofi, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797353
- Sponsor's protocol ID
- 2787-Ped-ERC-13
- Acronym
- SRC
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2016
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
- ClinicalTrials.gov ID
- NCT02797353
- Acronym / sponsor ID
- SRC / 2787-Ped-ERC-13
- Conditions
- Antepartum Hemorrhage, Postpartum Hemorrhage, Anemia, Eclampsia, Neonatal Sepsis, Birth Asphyxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The International Federation of Red Cross and Red Crescent Societies
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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 Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected. Aga Khan University Pakistan is intending to implement a service delivery project for the improvement of Maternal Neonatal and Child health situation through evidence based MNCH interventions.
Detailed description
The Aga Khan University is implementing together with its local partners a MNCH project in five Union Councils (UC) in Dadu District in Sindh Province. The project will scale up the already existing health services for MNCH in the district referral hospital and the five Basic Health Units (BHUs), one in each UC. Institutional based services as well as their scope for outreach to pregnant women, mothers and children in the communities with the aim to promote safe deliveries as per WHO guidelines and Government policy will be enhanced. In order to deliver quality services, the facilities will be renovated and equipped and the capacity of the existing staff will be strengthened through different training courses in MNCH. In addition professionally trained Lady Health Visitors will be introduced in the BHUs, who will conduct all maternal services including deliveries in the BHU and the communities. The health staff is furthermore responsible to establish and facilitate community support groups and raise communal awareness for the importance of mother and child health care as well as safe deliveries with skilled attendants. Operational research is an integral part of this pilot project. The research validates the progress and improvement of maternal and child health indicators. The results will be used to lobby the scale up of MNCH interventions with the Ministry of Health in Pakistan.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Maternal Neonatal and Child Health InterventionsAntenatal Care, Post natal care, Skilled birth attendance, recognition and referrals of complicated cases, immunization |
| Control | No intervention | –This arm will receive the standard MNCH services as outlined in the MNCH policy of Government of Pakistan |
Who may qualify
- Ages
- 1 day to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Be a resident of target areas and consent to participate in the study
Key exclusion criteria (1 listed)
- Do not fulfill the residence and consent criteria
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 |
|---|---|---|
| Maternal Neonatal and Child Health InterventionsAntenatal care, postnatal care, skilled birth attendance, recognition and referral of complicated cases, immunization | Other | Intervention Arm |
Primary outcome
Maternal, Neonatal and infant mortality
Time frame: 24 months
A 20% reduction in mortality rates is expected
4 secondary outcomes
Antenatal Care
Time frame: 12 months
Skilled Birth attendance
Time frame: 12 months
Essential Neonatal Care
Time frame: 24 months
Child hood Immunization Rates
Time frame: 24 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 22 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Antepartum Hemorrhage
Recruiting
Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta
Placenta Previa, Placenta Accreta Spectrum
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.
Sajid Soofi, FCPS principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Neonatal and Child Health Interventions in people with Antepartum Hemorrhage and Postpartum Hemorrhage, run by Aga Khan University.
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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Maternal, Neonatal and infant mortality (time frame: 24 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 22 Jun 2020.