Neonatal DeathNCT03438110
Asia Pregnancy Outcomes Study
An observational study of Neonatal Death and Stillbirth, run by RTI International at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Death, Stillbirth
- How many people
- 1,226 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2018to 12 Feb 2020
- Phase
- Observational
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Women in labor and delivery with imminent preterm delivery and/or stillbirth
Who cannot join
- Induced (medical) abortion
- Unable to determine the gestational age at delivery
- Gestational age < 20 weeks at delivery
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Pakistan2 sites
National Institute of Child Health
Karachi, Pakistan
Jinnah Postgrad Medical Center
Karachi
About this study
Official title: Project to Understand & Research Preterm Pregnancy Outcomes-South Asia (PURPOSe)
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.
Read the detailed description
Neonatal mortality is common in South Asia and sub-Saharan Africa with rates as high as 40 to 50 per 1,000 live births in some countries compared to rates as low as 2 per 1,000 live births in Scandinavia. Worldwide, at least 2.6 million neonatal deaths occur annually, with more than one-third attributed directly to preterm birth. Globally, the risk of death from preterm birth is highest in south Asia and sub-Saharan Africa. Although the mortality rates are often higher in Africa, numerically, more infants die in south Asia. Preterm neonates die from prematurity-related complications such as respiratory distress syndrome (RDS), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH), and conditions not specifically caused by prematurity such as asphyxia, infection, and congenital anomalies. However, few cause of death studies-especially in low-resource settings in low and middle-income countries (LMIC)-have determined the specific causes of preterm death, instead attributing all neonatal deaths of infants <37 weeks to prematurity. Furthermore, little is known about the causes of death among stillbirths in preterm births in LMIC and especially the specific types of infections associated with stillbirth.
One of the important goals of international organizations is to reduce neonatal mortality in LMIC, with recent efforts highlighting the importance of reducing neonatal mortality in preterm infants. One impeding factor is lack of knowledge about the medical conditions that cause neonatal mortality in preterm infants and the circumstances under which these babies die. It is crucial not only to know the major medical, infectious and pathological causes, but also the sequence of events that led to the death. Answers to these questions are important not only to understand the cause of death in preterm infants, but also to propose effective treatments to reduce the neonatal deaths in live-born preterm infants.
Less is known about the causes of stillbirth than neonatal mortality in LMIC and Asia specifically. Stillbirth rates are also highest in south Asia and sub-Saharan Africa, with rates as high as 40-50/1,000 births compared to 2-3/1,000 in Scandinavia. The highest reported rates of stillbirth occur in Pakistan. In most countries, the stillbirth rates are equivalent to or greater than the neonatal mortality rates with about 3 million third trimester stillbirths occurring yearly. In high-income countries (HIC), 50% of the stillbirths occur prior to 28 weeks and fully 80% occur prior to term. The percent of stillbirths occurring in the preterm period in LMIC is unknown, but probably lower than the HIC rate of 80%, likely in the range of 50%. Thus, the researchers estimate that most the perinatal mortality in LMIC occurs in infants born preterm.
Stillbirths are caused by a variety of maternal and fetal conditions, including placental abruption, obstructed labor, preeclampsia, placental malfunction, infection, congenital anomalies and cord complications, conditions that also contribute to neonatal mortality. The distribution of these causes and the sequence of events leading to the stillbirth in LMIC are generally unknown. One study suggests that when assessing preterm birth, the true picture of preterm birth may be obscured if stillbirth is excluded. In this cross-sectional study of 29 countries, researchers found that inclusion of stillbirths substantially increased the preterm birth rate in all countries. The degree of change was particularly large in LMIC, with the preterm birth rate increasing by 18% when stillbirths were included. Thus, because of the substantial overlap in etiology between preterm neonatal deaths and preterm stillbirths, and the large contribution of stillbirths to the preterm birth rate, the researchers believe that it would be appropriate to evaluate cause of death in all preterm deaths whether live- or stillborn.
For both neonatal deaths and stillbirths, infectious causes of death are often not identified and have largely been under-reported in low-resource settings where both logistics and technology may limit investigations into infections. From a literature review of epidemiological studies and case reports, the list of pathogens potentially causing a stillbirth or neonatal death likely extends to over 100 organisms. Since the identification of pathogens responsible for fetal or neonatal death may not be obtained from blood cultures alone, the identification process becomes more complicated with testing required of specific tissues such as the placenta, and fetal or neonatal organs, often with molecular assays.
In many areas in Asia, most deliveries now occur in health facilities. Despite the dramatic increase in hospital deliveries in the last decade in this region, little reduction in neonatal mortality or stillbirth has been realized. Thus, the Asian study will augment other efforts through examination of the specific causes of preterm neonatal deaths in Asia, and expand understanding of the contribution of preterm birth to perinatal mortality through inclusion of stillbirths. Determining the main causes and risk factors for perinatal mortality will ultimately inform potential strategies to reduce the high neonatal mortality and stillbirth rates currently seen in south Asia. This is a prospective, observational study aimed to better understand causes of stillbirths and neonatal deaths among preterm livebirths in Karachi, Pakistan, and Davengere, India.
- Conditions
- Neonatal Death, Stillbirth
- Keywords
- Preterm birth, Neonatal death, Stillbirth, Asia, Africa
- Medical subject headings
- Perinatal Death, Stillbirth, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of Death
Cause of death among preterm deaths and stillbirths.
Measured: At time of study enrollment of mother
Secondary outcomes (3)
Neonatal Death
Evaluate the rate of mortality by gestational age and birth weight by taking weight post-mortem and estimating gestational age
Measured: At time of study enrollment of mother
Preterm Death and Stillbirth Placental Pathology
Determine the placental pathology associated with stillbirth and preterm deaths by performing post-mortem autopsy
Measured: At time of study enrollment of mother
Stillbirth and Preterm Death Pathogens
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
Measured: Following stillbirth or infant death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Sep 2018
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Neonatal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,226 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth McClure, RTI International
- Investigators
- Elizabeth McClure, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438110
- Sponsor's protocol ID
- CP COD
- Status last verified
- Aug 2025
- First submitted
- 29 Jan 2018
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2015 Child Mortality Collaborators. Global, regional, national, and selected subnational levels of stillbirths, neonatal, infant, and under-5 mortality, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1725-1774. doi: 10.1016/S0140-6736(16)31575-6.
PubMed 27733285Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
PubMed 25280870Oza S, Lawn JE, Hogan DR, Mathers C, Cousens SN. Neonatal cause-of-death estimates for the early and late neonatal periods for 194 countries: 2000-2013. Bull World Health Organ. 2015 Jan 1;93(1):19-28. doi: 10.2471/BLT.14.139790. Epub 2014 Nov 17.
PubMed 25558104Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
PubMed 24625129Lackritz EM, Wilson CB, Guttmacher AE, Howse JL, Engmann CM, Rubens CE, Mason EM, Muglia LJ, Gravett MG, Goldenberg RL, Murray JC, Spong CY, Simpson JL; Preterm Birth Research Priority Setting Group. A solution pathway for preterm birth: accelerating a priority research agenda. Lancet Glob Health. 2013 Dec;1(6):e328-30. doi: 10.1016/S2214-109X(13)70120-7. Epub 2013 Nov 15. No abstract available.
PubMed 25104592McClure EM, Bose CL, Garces A, Esamai F, Goudar SS, Patel A, Chomba E, Pasha O, Tshefu A, Kodkany BS, Saleem S, Carlo WA, Derman RJ, Hibberd PL, Liechty EA, Hambidge KM, Krebs NF, Bauserman M, Koso-Thomas M, Moore J, Wallace DD, Jobe AH, Goldenberg RL. Global network for women's and children's health research: a system for low-resource areas to determine probable causes of stillbirth, neonatal, and maternal death. Matern Health Neonatol Perinatol. 2015 May 4;1:11. doi: 10.1186/s40748-015-0012-7. eCollection 2015.
PubMed 27057328Engmann C, Jehan I, Ditekemena J, Garces A, Phiri M, Mazariegos M, Chomba E, Pasha O, Tshefu A, Hemed Y, McClure EM, Thorsten V, Bann C, Goldenberg RL, Bose C, Setel P, Carlo WA, Wright LL. Using verbal autopsy to ascertain perinatal cause of death: are trained non-physicians adequate? Trop Med Int Health. 2009 Dec;14(12):1496-504. doi: 10.1111/j.1365-3156.2009.02395.x. Epub 2009 Oct 1.
PubMed 19799757McClure EM, Garces A, Saleem S, Moore JL, Bose CL, Esamai F, Goudar SS, Chomba E, Mwenechanya M, Pasha O, Tshefu A, Patel A, Dhaded SM, Tenge C, Marete I, Bauserman M, Sunder S, Kodkany BS, Carlo WA, Derman RJ, Hibberd PL, Liechty EA, Hambidge KM, Krebs NF, Koso-Thomas M, Miodovnik M, Wallace DD, Goldenberg RL. Global Network for Women's and Children's Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system. BJOG. 2018 Jan;125(2):131-138. doi: 10.1111/1471-0528.14493. Epub 2017 Jan 31.
PubMed 28139875Stillbirth Collaborative Research Network Writing Group. Causes of death among stillbirths. JAMA. 2011 Dec 14;306(22):2459-68. doi: 10.1001/jama.2011.1823.
PubMed 22166605Belizan JM, McClure EM, Goudar SS, Pasha O, Esamai F, Patel A, Chomba E, Garces A, Wright LL, Koso-Thomas M, Moore J, Althabe F, Kodkany BS, Sami N, Manasyan A, Derman RJ, Liechty EA, Hibberd P, Carlo WA, Hambidge KM, Buekens P, Jobe AH, Goldenberg RL. Neonatal death in low- to middle-income countries: a global network study. Am J Perinatol. 2012 Sep;29(8):649-56. doi: 10.1055/s-0032-1314885. Epub 2012 May 29.
PubMed 22644832Goldenberg RL, McClure EM, Saleem S, Reddy UM. Infection-related stillbirths. Lancet. 2010 Apr 24;375(9724):1482-90. doi: 10.1016/S0140-6736(09)61712-8. Epub 2010 Mar 9.
PubMed 20223514Castillo P, Ussene E, Ismail MR, Jordao D, Lovane L, Carrilho C, Lorenzoni C, Lacerda MV, Palhares A, Rodriguez-Carunchio L, Martinez MJ, Vila J, Bassat Q, Menendez C, Ordi J. Pathological Methods Applied to the Investigation of Causes of Death in Developing Countries: Minimally Invasive Autopsy Approach. PLoS One. 2015 Jun 30;10(6):e0132057. doi: 10.1371/journal.pone.0132057. eCollection 2015.
PubMed 26126191Jehan I, Harris H, Salat S, Zeb A, Mobeen N, Pasha O, McClure EM, Moore J, Wright LL, Goldenberg RL. Neonatal mortality, risk factors and causes: a prospective population-based cohort study in urban Pakistan. Bull World Health Organ. 2009 Feb;87(2):130-8. doi: 10.2471/blt.08.050963.
PubMed 19274365McClure EM, Goldenberg RL, Jobe AH, Miodovnik M, Koso-Thomas M, Buekens P, Belizan J, Althabe F. Reducing neonatal mortality associated with preterm birth: gaps in knowledge of the impact of antenatal corticosteroids on preterm birth outcomes in low-middle income countries. Reprod Health. 2016 May 24;13(1):61. doi: 10.1186/s12978-016-0180-6.
PubMed 27221397Saleem S, Reza T, McClure EM, Pasha O, Moss N, Rouse DJ, Bartz J, Goldenberg RL. Chlorhexidine vaginal and neonatal wipes in home births in Pakistan: a randomized controlled trial. Obstet Gynecol. 2007 Nov;110(5):977-85. doi: 10.1097/01.AOG.0000285653.17869.26.
PubMed 17978107
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project to Understand & Research Preterm Pregnancy Outcomes-South Asia (PURPOSe)
- ClinicalTrials.gov ID
- NCT03438110
- Acronym / sponsor ID
- CP COD
- Conditions
- Neonatal Death, Stillbirth
- Keywords
- Preterm birth, Neonatal death, Stillbirth, Asia, Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,226 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 19 Feb 2018 (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.
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.
Detailed description
Neonatal mortality is common in South Asia and sub-Saharan Africa with rates as high as 40 to 50 per 1,000 live births in some countries compared to rates as low as 2 per 1,000 live births in Scandinavia. Worldwide, at least 2.6 million neonatal deaths occur annually, with more than one-third attributed directly to preterm birth. Globally, the risk of death from preterm birth is highest in south Asia and sub-Saharan Africa. Although the mortality rates are often higher in Africa, numerically, more infants die in south Asia. Preterm neonates die from prematurity-related complications such as respiratory distress syndrome (RDS), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH), and conditions not specifically caused by prematurity such as asphyxia, infection, and congenital anomalies. However, few cause of death studies-especially in low-resource settings in low and middle-income countries (LMIC)-have determined the specific causes of preterm death, instead attributing all neonatal deaths of infants <37 weeks to prematurity. Furthermore, little is known about the causes of death among stillbirths in preterm births in LMIC and especially the specific types of infections associated with stillbirth.
One of the important goals of international organizations is to reduce neonatal mortality in LMIC, with recent efforts highlighting the importance of reducing neonatal mortality in preterm infants. One impeding factor is lack of knowledge about the medical conditions that cause neonatal mortality in preterm infants and the circumstances under which these babies die. It is crucial not only to know the major medical, infectious and pathological causes, but also the sequence of events that led to the death. Answers to these questions are important not only to understand the cause of death in preterm infants, but also to propose effective treatments to reduce the neonatal deaths in live-born preterm infants.
Less is known about the causes of stillbirth than neonatal mortality in LMIC and Asia specifically. Stillbirth rates are also highest in south Asia and sub-Saharan Africa, with rates as high as 40-50/1,000 births compared to 2-3/1,000 in Scandinavia. The highest reported rates of stillbirth occur in Pakistan. In most countries, the stillbirth rates are equivalent to or greater than the neonatal mortality rates with about 3 million third trimester stillbirths occurring yearly. In high-income countries (HIC), 50% of the stillbirths occur prior to 28 weeks and fully 80% occur prior to term. The percent of stillbirths occurring in the preterm period in LMIC is unknown, but probably lower than the HIC rate of 80%, likely in the range of 50%. Thus, the researchers estimate that most the perinatal mortality in LMIC occurs in infants born preterm.
Stillbirths are caused by a variety of maternal and fetal conditions, including placental abruption, obstructed labor, preeclampsia, placental malfunction, infection, congenital anomalies and cord complications, conditions that also contribute to neonatal mortality. The distribution of these causes and the sequence of events leading to the stillbirth in LMIC are generally unknown. One study suggests that when assessing preterm birth, the true picture of preterm birth may be obscured if stillbirth is excluded. In this cross-sectional study of 29 countries, researchers found that inclusion of stillbirths substantially increased the preterm birth rate in all countries. The degree of change was particularly large in LMIC, with the preterm birth rate increasing by 18% when stillbirths were included. Thus, because of the substantial overlap in etiology between preterm neonatal deaths and preterm stillbirths, and the large contribution of stillbirths to the preterm birth rate, the researchers believe that it would be appropriate to evaluate cause of death in all preterm deaths whether live- or stillborn.
For both neonatal deaths and stillbirths, infectious causes of death are often not identified and have largely been under-reported in low-resource settings where both logistics and technology may limit investigations into infections. From a literature review of epidemiological studies and case reports, the list of pathogens potentially causing a stillbirth or neonatal death likely extends to over 100 organisms. Since the identification of pathogens responsible for fetal or neonatal death may not be obtained from blood cultures alone, the identification process becomes more complicated with testing required of specific tissues such as the placenta, and fetal or neonatal organs, often with molecular assays.
In many areas in Asia, most deliveries now occur in health facilities. Despite the dramatic increase in hospital deliveries in the last decade in this region, little reduction in neonatal mortality or stillbirth has been realized. Thus, the Asian study will augment other efforts through examination of the specific causes of preterm neonatal deaths in Asia, and expand understanding of the contribution of preterm birth to perinatal mortality through inclusion of stillbirths. Determining the main causes and risk factors for perinatal mortality will ultimately inform potential strategies to reduce the high neonatal mortality and stillbirth rates currently seen in south Asia. This is a prospective, observational study aimed to better understand causes of stillbirths and neonatal deaths among preterm livebirths in Karachi, Pakistan, and Davengere, India.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Women in labor and delivery with imminent preterm delivery and/or stillbirth
Key exclusion criteria (3 listed)
- Induced (medical) abortion
- Unable to determine the gestational age at delivery
- Gestational age < 20 weeks at delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cause of Death
Time frame: At time of study enrollment of mother
Cause of death among preterm deaths and stillbirths.
3 secondary outcomes
Neonatal Death
Time frame: At time of study enrollment of mother
Preterm Death and Stillbirth Placental Pathology
Time frame: At time of study enrollment of mother
Stillbirth and Preterm Death Pathogens
Time frame: Following stillbirth or infant death
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 13 Aug 2025.
- Background: PubMed 27733285GBD 2015 Child Mortality Collaborators. Global, regional, national, and selected subnational levels of stillbirths, neonatal, infant, and under-5 mortality, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1725-1774. doi: 10.1016/S0140-6736(16)31575-6.
- Background: PubMed 25280870Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
- Background: PubMed 25558104Oza S, Lawn JE, Hogan DR, Mathers C, Cousens SN. Neonatal cause-of-death estimates for the early and late neonatal periods for 194 countries: 2000-2013. Bull World Health Organ. 2015 Jan 1;93(1):19-28. doi: 10.2471/BLT.14.139790. Epub 2014 Nov 17.
- Background: PubMed 24625129Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
- Background: PubMed 25104592Lackritz EM, Wilson CB, Guttmacher AE, Howse JL, Engmann CM, Rubens CE, Mason EM, Muglia LJ, Gravett MG, Goldenberg RL, Murray JC, Spong CY, Simpson JL; Preterm Birth Research Priority Setting Group. A solution pathway for preterm birth: accelerating a priority research agenda. Lancet Glob Health. 2013 Dec;1(6):e328-30. doi: 10.1016/S2214-109X(13)70120-7. Epub 2013 Nov 15. No abstract available.
- Background: PubMed 27057328McClure EM, Bose CL, Garces A, Esamai F, Goudar SS, Patel A, Chomba E, Pasha O, Tshefu A, Kodkany BS, Saleem S, Carlo WA, Derman RJ, Hibberd PL, Liechty EA, Hambidge KM, Krebs NF, Bauserman M, Koso-Thomas M, Moore J, Wallace DD, Jobe AH, Goldenberg RL. Global network for women's and children's health research: a system for low-resource areas to determine probable causes of stillbirth, neonatal, and maternal death. Matern Health Neonatol Perinatol. 2015 May 4;1:11. doi: 10.1186/s40748-015-0012-7. eCollection 2015.
- Background: PubMed 19799757Engmann C, Jehan I, Ditekemena J, Garces A, Phiri M, Mazariegos M, Chomba E, Pasha O, Tshefu A, Hemed Y, McClure EM, Thorsten V, Bann C, Goldenberg RL, Bose C, Setel P, Carlo WA, Wright LL. Using verbal autopsy to ascertain perinatal cause of death: are trained non-physicians adequate? Trop Med Int Health. 2009 Dec;14(12):1496-504. doi: 10.1111/j.1365-3156.2009.02395.x. Epub 2009 Oct 1.
- Background: PubMed 28139875McClure EM, Garces A, Saleem S, Moore JL, Bose CL, Esamai F, Goudar SS, Chomba E, Mwenechanya M, Pasha O, Tshefu A, Patel A, Dhaded SM, Tenge C, Marete I, Bauserman M, Sunder S, Kodkany BS, Carlo WA, Derman RJ, Hibberd PL, Liechty EA, Hambidge KM, Krebs NF, Koso-Thomas M, Miodovnik M, Wallace DD, Goldenberg RL. Global Network for Women's and Children's Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system. BJOG. 2018 Jan;125(2):131-138. doi: 10.1111/1471-0528.14493. Epub 2017 Jan 31.
- Background: PubMed 22166605Stillbirth Collaborative Research Network Writing Group. Causes of death among stillbirths. JAMA. 2011 Dec 14;306(22):2459-68. doi: 10.1001/jama.2011.1823.
- Background: PubMed 22644832Belizan JM, McClure EM, Goudar SS, Pasha O, Esamai F, Patel A, Chomba E, Garces A, Wright LL, Koso-Thomas M, Moore J, Althabe F, Kodkany BS, Sami N, Manasyan A, Derman RJ, Liechty EA, Hibberd P, Carlo WA, Hambidge KM, Buekens P, Jobe AH, Goldenberg RL. Neonatal death in low- to middle-income countries: a global network study. Am J Perinatol. 2012 Sep;29(8):649-56. doi: 10.1055/s-0032-1314885. Epub 2012 May 29.
- Background: PubMed 20223514Goldenberg RL, McClure EM, Saleem S, Reddy UM. Infection-related stillbirths. Lancet. 2010 Apr 24;375(9724):1482-90. doi: 10.1016/S0140-6736(09)61712-8. Epub 2010 Mar 9.
- Background: PubMed 26126191Castillo P, Ussene E, Ismail MR, Jordao D, Lovane L, Carrilho C, Lorenzoni C, Lacerda MV, Palhares A, Rodriguez-Carunchio L, Martinez MJ, Vila J, Bassat Q, Menendez C, Ordi J. Pathological Methods Applied to the Investigation of Causes of Death in Developing Countries: Minimally Invasive Autopsy Approach. PLoS One. 2015 Jun 30;10(6):e0132057. doi: 10.1371/journal.pone.0132057. eCollection 2015.
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Mucopolysaccharidosis Type II, Metabolic Diseases
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Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
Maternal Health, Neonatal Health
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.
Elizabeth McClure, PhD principal investigator
RTI International
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Death and Stillbirth, run by RTI International at 3 sites in 2 countries.
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 3 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan, India. 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?
Cause of Death (time frame: At time of study enrollment of mother). 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 NCT03438110, which also lists 23 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 13 Aug 2025.