Early Postpartum and Newborn CareNCT01389219
Post Partum Maternal and Neonatal Intervention Package
A study testing Intervention in people with Early Postpartum and Newborn Care and Maternal Mortality, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction… Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Early Postpartum and Newborn Care, Maternal Mortality, Neonatal Mortality
- What is being tested?
- Intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2007to Sep 2010
- 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 Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates delivered within the study area
Who cannot join
- Neonates delivered outside the study area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Partum Maternal and Neonatal Intervention Package: A Cluster Randomized Control Trial in District Sukkur, Pakistan
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan
Read the detailed description
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan.
- Being tested
- Intervention
- Keywords
- Post partum, Neonate, community health care workers
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
A comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of;
- Provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation (iron \& vitamin A), cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases.
- Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness.
- Nutrition counseling regarding immediate and exclusive breastfeeding and optimum postpartum diets.
- Danger signs of newborn illnesses and maternal complications associated with labor and the postpartum period, care seeking. Early referral for subsequent maternal and newborn morbidities, such as anemia, postpartum depression, fistulas, prolapsed uterus and infections.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control arm |
| Intervention clusters | Other | Focus is to increase the number of visits by LHWs to the newborn baby and to ensure that this visit occurs within 48-72 hours of birth. The purpose of this visit was the provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation, cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visit by LHWs
The aim is to increase the visits of LHWs and examine the newborn within 48- 72 hours of birth
Measured: Within 48 - 72 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startOct 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Postpartum and Newborn CareStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Pakistan Ministry of Health, John Snow, Inc., Population Council
- Investigators
- Zulfiqar A Bhutta, MBBS, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389219
- Sponsor's protocol ID
- 770-Ped/ERC-06
- Status last verified
- Oct 2007
- First submitted
- 6 Jul 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Partum Maternal and Neonatal Intervention Package: A Cluster Randomized Control Trial in District Sukkur, Pakistan
- ClinicalTrials.gov ID
- NCT01389219
- Acronym / sponsor ID
- 770-Ped/ERC-06
- Keywords
- Post partum, Neonate, community health care workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Pakistan Ministry of Health, John Snow, Inc., Population Council
- Study start
- Oct 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Jul 2011 (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.
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan
Detailed description
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control arm |
| Intervention clusters | Other | Other: InterventionFocus is to increase the number of visits by LHWs to the newborn baby and to ensure that this visit occurs within 48-72 hours of birth. The purpose of this visit was the provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation, cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates delivered within the study area
Key exclusion criteria (1 listed)
- Neonates delivered outside the study area
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 |
|---|---|---|
| InterventionA comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of; 1. Provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation (iron \& vitamin A), cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases. 2. Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness. 3. Nutrition counseling regarding immediate and exclusive breastfeeding and optimum postpartum diets. 5. Danger signs of newborn illnesses and maternal complications associated with labor and the postpartum period, care seeking. Early referral for subsequent maternal and newborn morbidities, such as anemia, postpartum depression, fistulas, prolapsed uterus and infections. | Other | Intervention clusters |
Primary outcome
Visit by LHWs
Time frame: Within 48 - 72 hours of birth
The aim is to increase the visits of LHWs and examine the newborn within 48- 72 hours of birth
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 8 Jul 2011.
Related trials for Early Postpartum and Newborn Care
Enrolling by invitation
The Effect of Neonatal Care Education Given to Primiparous Mothers in the Last Trimester on Mothers' Self-Efficacy Perception, Prenatal and Maternal Bonding in the Early Postpartum Period
Primiparous Pregnant Women in the Last Trimester
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.
Zulfiqar A Bhutta, MBBS, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Early Postpartum and Newborn Care and Maternal Mortality, 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 8 Jul 2011. 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?
Visit by LHWs (time frame: Within 48 - 72 hours of birth). 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 8 Jul 2011.