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Perinatal ProblemsNCT02412293

Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration

A study testing Health Education & Promotion, Training of Health Workers and Community Mobilization in people with Perinatal Problems and Still Births, 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
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Trial summary

There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Perinatal Problems, Still Births, Neonatal Deaths
What is being tested?
Health Education & Promotion, Training of Health Workers and Community Mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,200 participants
Where
1 sitePakistan
Study dates
Jul 2001to Sep 2007
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 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women \& participants who agree to participate in the study

Who cannot join

  • Pregnant women \& participants who disagree to participate in the study

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Aga Khan University

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan.

A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.

Read the detailed description

The World Health Organization estimates that globally over 9 million infants die annually before birth or in the first few weeks of life, and that the majority of these deaths occur in the neonatal period. The bulk of these deaths result from pregnancy or delivery associated complications, premature births, intrauterine growth retardation and infectious diseases.

There are over seven million perinatal deaths annually globally mostly in developing countries. Almost 4 million newborns suffer moderate to severe birth asphyxia, with at least 800,000 dying and probably a higher number developing sequel such as epilepsy, mental retardation, cerebral palsy and learning disabilities. A recent community based study in Zimbabwe, which audited perinatal mortality showed the commonest single cause was perinatal asphyxia and an avoidable factor was detected in 76% of cases. In another population based study in Bangladesh, which showed a perinatal mortality rate of 75 per 1000 births (37 stillbirths, 38 first week deaths), the major causes of early neonatal death were attributed to a small size at birth (54%), birth asphyxia (26%), and tetanus (8%). In Bangalore, South India a prospective hospital based study of 4572 births showed a perinatal mortality of 43/1000. Using the Wiggles worth's classification , 24% were considered due to birth asphyxia, even after exclusion of the premature group. Similarly a recent evaluation of a large hospital-based birth cohort for perinatal deaths in Karachi according to the Wiggles worth's criteria, indicated that almost 30% of all deaths were related to acute asphyxia.

Hypotheses

  1. A concerted and coordinated community-based program of training first level primary care workers i.e. TBAs, LHWs, lady health visitors and rural health center physicians in the prevention, early recognition and management of common perinatal / neonatal problems will result in a significant reduction in perinatal and neonatal mortality in the Northern areas of Pakistan.
  2. A coordinated program of community education and awareness in the importance of perinatal care, prevention and recognition of neonatal problems will lead to improved neonatal health, better recognition of neonatal problems and care-seeking behavior.
  3. The strengthening of secondary care perinatal and newborn care and reproductive health services will lead to improved referral patterns for perinatal / neonatal problems with better outcome.
  4. Increasing the community awareness of neonatal problems and training of first level primary care workers will result in better domiciliary management of neonatal problems.

Phase 1: Formative Research The objectives of this first phase of the study are as follows

  1. Determination of preconditions for studying care seeking practices (referral system, availability of BHU staff, doctors, LHVs)
  2. Focusing questions for formative research on care-seeking and causes of perinatal / neonatal morbidity / mortality by a modified perinatal / neonatal verbal autopsy)
  3. Rapid anthropological assessment of care-seeking behavior
  4. Illness Episode and Channel Survey
  5. Analysis of results of formative research
  6. Identification of desired behaviors and changes
  7. Selection of behaviors for intervention and their potential acceptability
  8. Acceptability of planned intervention(s) for families, communities and care providers and possible additional structural changes

This initial phase of formative research, will be conducted in the Hunza-Karimabad/Nagar/Gojal tehsils of the Gilgit District of the Northern areas. A combined methodology of KAP survey and verbal/social autopsy will be employed. These will include an in-depth evaluation of knowledge, attitude and practices of families and primary care givers (TBAs, LHWs, LHVs and BHU/RHC staff) with regards to

  • Common causes of maternal morbidity in pregnancy
  • Maternal nutrition and dietary patterns in pregnancy
  • Determinants of care seeking behavior during pregnancy and labor
  • Domiciliary versus hospital births
  • Selection of care givers by families
  • Reasons for referral by primary care givers
  • Perception and recognition of danger signs during child birth by families and care givers
  • Immediate and early newborn care practices (colostrum and prelacteal feeding, breastfeeding, cord care, temperature regulation, swaddling, skin care etc).
  • Concepts of early neonatal morbidity and health seeking behavior;
  • Risk factors for birth asphyxia and meconium aspiration
  • Low birth weight and temperature regulation
  • Neonatal infection (local and generalized)
  • Seizures or spasms
  • Respiratory problems
  • Jaundice
  • Feeding difficulty

Phase 2: Implementation phase

The overall objectives of this phase of the intervention are introduction and implementation of simple education and training materials for families and caregivers for community-based perinatal and newborn care by means of a phased introduction of the program in the area. In addition primary care givers in the target villages of the study area would receive training in stabilization and early referral of sick newborns for secondary care.

The intervention package, consisting of awareness creation about positive maternal and newborn health care practices at household level such as importance of; seeking antenatal care, adequate nutrition during pregnancy and lactation, skilled birth attendance, early initiation of breastfeeding, delayed bathing recognition of danger signs that warrant for early referrals, will be developed in collaboration with the Aga Khan Health Services, Pakistan. The practices will promote though community mobilization and education strategy that included formation of Community Health Committee (CHC) and group education sessions using flip charts and videos.

The LHWs and CHWs in the intervention areas will provide with enhanced trainings on causes of perinatal and newborn mortality and risky maternal and newborn care practices and expecting to transmit the knowledge to the families to avoid such practices. They will receive training in delivering the intervention package through standardized workshops including hands on practice on use of specific Information Education and Communication (IEC) materials developed for this purpose. The recently modified and simplified integrated management of neonatal and childhood illnesses (IMNCI) based system formed the basis of screening, recognition of danger signs and referral. The CHWs will deliver interventions in LHW uncovered areas within the intervention areas.

Control areas will continue to receive the routine services of governmental and non-governmental organizations in the area. But the public health care facilities of both intervention and control areas will receive similar competency based trainings in stabilization and early referral of sick newborns for secondary care.

The intervention Package The LHWs and CHWs will receive trainings on IMNCI-based training package. They will also receive orientation about the purpose of the project and how can they facilitate group education session by using flip charts and videos. The community-based health education sessions will be introduced targeting local communities to sensitize them regarding maternal, perinatal and newborn health issues.

In addition to this, Two days training workshops will be organized to train TBAs in intervention areas on "Clean Delivery Practices" at nearest health facilities. The UNICEF manual of (DAI) training will be adopted for this training.

The intervention package will be delivered through monthly household visits, one-to-one counseling sessions with pregnant women and video sessions in communities. Additionally, LHWs and CHWs in the intervention areas will record information about home visits, newborn illnesses, referrals, live births and deaths on special format designed for this project.

For community mobilization and education, two types of tools will be used one group session by use of flip charts and group session by use of video. Participants will be invited from all Muhallas (Sub-geographical distribution of the village population) to attend the session, facilitated by LHW/CHW to organize the session. Separate sessions will be organized for males and females. One session per area will be organized on quarterly basis in local school or LHW health house or CHW household within intervention areas. Target groups will be women of reproductive age, adolescent girls, fathers, mothers and fathers in law and mothers in law.

Being tested
Health Education & Promotion, Training of Health Workers, Community Mobilization
Keywords
Perinatal, neonatal, newborn, mortality
Medical subject headings
Perinatal Death

What participants receive

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

  • Health Education & PromotionBehavioural

    Promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level.

  • Training of Health WorkersOther

    Training of health workers on recognition of danger sign that warrant referral to health care service.

  • Community MobilizationBehavioural

    Community mobilization activities included formation of community health committees and creation of support for the uptake of the interventions.

Study groups in NCT02412293
Study groupRoleWhat they receive
InterventionExperimentalHealth Education \& Promotion: LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period in intervention areas. Training of Health Workers: The LHWs and CHWs will receive trainings on IMNCI-based training package. Community Mobilization: For community mobilization and education, two types of tools will be used one group session by use of flip charts and group session by use of video.
Receives: Behavioral: Health Education & Promotion; Other: Training of Health Workers; Behavioral: Community Mobilization
ControlNo interventionControl areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area.

What is being measured

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

  1. Reduction in perinatal and neonatal mortality

    Baseline \& Endline Surveys

    Measured: 3 years

Secondary outcomes (5)
  1. Improvements in antenatal care practices

    Baseline \& Endline Surveys

    Measured: 3 Years

  2. Improvements in cord application practices

    Baseline \& Endline Surveys

    Measured: 3 Years

  3. Improvements in delaying first bath after birth

    Baseline \& Endline Surveys

    Measured: 3 Years

  4. Improvements in colostrum administration

    Baseline \& Endline Surveys

    Measured: 3 Years

  5. Improvements in initiation of breastfeeding practices within 1 hour after birth

    Baseline \& Endline Surveys

    Measured: 3 Years

Timeline

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

  1. First posted9 Apr 2015 (estimated)
  2. Study startJul 2001
  3. Primary completionFeb 2006
  4. Study completionSep 2007

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
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
3,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02412293
Sponsor's protocol ID
AKU-AKHSP
Status last verified
Apr 2015
First submitted
31 Mar 2015
Last updated
9 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Reducing Perinatal and Neonatal Mortality. Child Health Research Project Special Report. 1999;3:1-48.

  • Costello AM. Perinatal health in developing countries. Trans R Soc Trop Med Hyg. 1993 Jan-Feb;87(1):1-2. doi: 10.1016/0035-9203(93)90395-7.

    PubMed 8465375
  • World Health Organization. Child health and development: health of the newborn. Geneva: World health Organization 1991.

  • De Muylder X. Perinatal mortality audit in a Zimbabwean district. Paediatr Perinat Epidemiol. 1989 Jul;3(3):284-93. doi: 10.1111/j.1365-3016.1989.tb00380.x.

    PubMed 2788880
  • Fauveau V, Wojtyniak B, Mostafa G, Sarder AM, Chakraborty J. Perinatal mortality in Matlab, Bangladesh: a community-based study. Int J Epidemiol. 1990 Sep;19(3):606-12. doi: 10.1093/ije/19.3.606.

    PubMed 2262255
  • Wigglesworth JS. Monitoring perinatal mortality. A pathophysiological approach. Lancet. 1980 Sep 27;2(8196):684-6. doi: 10.1016/s0140-6736(80)92717-8. No abstract available.

    PubMed 6106794
  • Raghuveer G. Perinatal deaths: relevance of Wigglesworth's classification. Paediatr Perinat Epidemiol. 1992 Jan;6(1):45-50. doi: 10.1111/j.1365-3016.1992.tb00743.x.

    PubMed 1553317
  • Bhutta ZA. Perinatal care in Pakistan. Proceedings of the Symposium on Priorities in Perinatal Care in South Asia. September 1998, Karachi, Pakistan.

  • Memon ZA, Khan GN, Soofi SB, Baig IY, Bhutta ZA. Impact of a community-based perinatal and newborn preventive care package on perinatal and neonatal mortality in a remote mountainous district in Northern Pakistan. BMC Pregnancy Childbirth. 2015 Apr 30;15:106. doi: 10.1186/s12884-015-0538-8.

    PubMed 25925407

Questions about this trial

What is this clinical trial studying?

A study testing Health Education & Promotion, Training of Health Workers and Community Mobilization in people with Perinatal Problems and Still Births, 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 9 Apr 2015. 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?

Reduction in perinatal and neonatal mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02412293, which also lists 9 linked publications.

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 9 Apr 2015.

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