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Asia Pregnancy Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438110
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
RTI International

Brief Summary:

Preterm birth is a major cause of child mortality and morbidity, most of which occurs in south-east Asia and sub-Saharan Africa. To date few neonatal cause of death studies, especially in low- and middle-income countries have determined the specific causes of preterm death, instead attributing all neonatal deaths of infants born at less than 37 weeks to prematurity. Infections are responsible for a large proportion of these deaths but because of complexity and costs associated with testing, little is known about the prevalence of infection-related deaths in preterm infants or the specific pathogens associated with mortality.

The primary objective of this study is to determine the cause of deaths among preterm births and stillbirths. Secondary outcomes include determining the specific pathogens responsible for infection-related deaths, potential preventability of these deaths and interventions which may reduce mortality. One site in India and one in Pakistan will include a total sample size of 700 (350 stillbirths and 350 preterm neonatal deaths) for 1,400 cases to be included in the cause of death analyses. All women who deliver a preterm birth or a stillbirth at the study hospitals will be eligible for inclusion. Among those who consent, an obstetric history, clinical obstetric and (if applicable) neonatal care will be collected as well as research investigations including ultrasound, x-ray, microbiology and minimally invasive tissue sampling and autopsy will be collected.

This study will align with other efforts to determine cause of death among infants and children and ultimately the results will inform future interventions to reduce neonatal mortality and stillbirth. The researchers emphasize that this study, with its focus on preterm neonatal mortality and stillbirth, will provide information not available elsewhere.


Condition or disease
Neonatal Death Stillbirth

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Project to Understand & Research Preterm Pregnancy Outcomes-South Asia (PURPOSe)
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth




Primary Outcome Measures :
  1. Cause of Death [ Time Frame: At time of study enrollment of mother ]
    Cause of death among preterm deaths and stillbirths.


Secondary Outcome Measures :
  1. Neonatal Death [ Time Frame: At time of study enrollment of mother ]
    Evaluate the rate of mortality by gestational age and birth weight by taking weight post-mortem and estimating gestational age

  2. Preterm Death and Stillbirth Placental Pathology [ Time Frame: At time of study enrollment of mother ]
    Determine the placental pathology associated with stillbirth and preterm deaths by performing post-mortem autopsy

  3. Stillbirth and Preterm Death Pathogens [ Time Frame: Following stillbirth or infant death ]
    Determine the pathogens associated with stillbirth and preterm deaths by examination of samples collected from fetus/neonate at autopsy and maternal samples collected at time of delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted at hospitals identified in Karachi, Pakistan and in Davangere, India. All women who deliver a stillbirth and/or who deliver preterm at a study hospital will be screened for study eligibility.
Criteria

Inclusion Criteria:

  • Women in labor and delivery with imminent preterm delivery and/or stillbirth

Exclusion Criteria:

  • Induced (medical) abortion
  • Unable to determine the gestational age at delivery
  • Gestational age < 20 weeks at delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438110


Locations
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India
J.J.M. Medical College Hospitals
Davangere, India
Pakistan
Jinnah Postgrad Medical Center
Karachi, Pakistan
National Institute of Child Health
Karachi, Pakistan
Sponsors and Collaborators
RTI International
Investigators
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Principal Investigator: Elizabeth McClure, PhD RTI International
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT03438110    
Other Study ID Numbers: CP COD
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTI International:
Preterm birth
Neonatal death
Stillbirth
Asia
Africa
Additional relevant MeSH terms:
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Stillbirth
Perinatal Death
Death
Pathologic Processes
Fetal Death
Pregnancy Complications