Understanding biological mechanisms underlying adverse birth outcomes in developing countries: protocol for a prospective cohort (AMANHI bio-banking) study.

AMANHI (Alliance for Maternal and Newborn Health Improvement) Bio–banking Study group), Abdullah H Baqui, Rasheda Khanam, Mohammad Sayedur Rahman, Aziz Ahmed, Hasna Hena Rahman, Mamun Ibne Moin, Salahuddin Ahmed, Fyezah Jehan, Imran Nisar, Atiya Hussain, Muhammad Ilyas, Aneeta Hotwani, Muhammad Sajid, Shahida Qureshi, Anita Zaidi, Sunil Sazawal, Said M Ali, Saikat Deb, Mohammed Hamad Juma, Usha Dhingra, Arup Dutta, Shaali Makame Ame, Caroline Hayward, Igor Rudan, Mike Zangenberg, Donna Russell, Sachiyo Yoshida, Ozren Polašek, Alexander Manu, Rajiv Bahl
Author Information
  1. Abdullah H Baqui: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  2. Rasheda Khanam: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  3. Mohammad Sayedur Rahman: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  4. Aziz Ahmed: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  5. Hasna Hena Rahman: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  6. Mamun Ibne Moin: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  7. Salahuddin Ahmed: Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  8. Fyezah Jehan: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  9. Imran Nisar: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  10. Atiya Hussain: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  11. Muhammad Ilyas: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  12. Aneeta Hotwani: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  13. Muhammad Sajid: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  14. Shahida Qureshi: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  15. Anita Zaidi: Department of Pediatrics and Child Health, Aga Khan University, Pakistan.
  16. Sunil Sazawal: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  17. Said M Ali: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  18. Saikat Deb: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  19. Mohammed Hamad Juma: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  20. Usha Dhingra: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  21. Arup Dutta: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  22. Shaali Makame Ame: Centre for Public Health Kinetics, India and Public Health Laboratory-IdC, Pemba, Tanzania.
  23. Caroline Hayward: University of Edinburgh: Centre for Global Health Research, Old Medical School, Edinburgh, Scotland, UK.
  24. Igor Rudan: University of Edinburgh: Centre for Global Health Research, Old Medical School, Edinburgh, Scotland, UK.
  25. Mike Zangenberg: World Health Organization (MCA/MRD), Geneva, Switzerland.
  26. Donna Russell: World Health Organization (MCA/MRD), Geneva, Switzerland.
  27. Sachiyo Yoshida: World Health Organization (MCA/MRD), Geneva, Switzerland.
  28. Ozren Polašek: University of Split School of Medicine, Split, Croatia.
  29. Alexander Manu: World Health Organization (MCA/MRD), Geneva, Switzerland.
  30. Rajiv Bahl: World Health Organization (MCA/MRD), Geneva, Switzerland.

Abstract

OBJECTIVES: The AMANHI study aims to seek for biomarkers as predictors of important pregnancy-related outcomes, and establish a biobank in developing countries for future research as new methods and technologies become available.
METHODS: AMANHI is using harmonised protocols to enrol 3000 women in early pregnancies (8-19 weeks of gestation) for population-based follow-up in pregnancy up to 42 days postpartum in Bangladesh, Pakistan and Tanzania, with collection taking place between August 2014 and June 2016. Urine pregnancy tests will be used to confirm reported or suspected pregnancies for screening ultrasound by trained sonographers to accurately date the pregnancy. Trained study field workers will collect very detailed phenotypic and epidemiological data from the pregnant woman and her family at scheduled home visits during pregnancy (enrolment, 24-28 weeks, 32-36 weeks & 38+ weeks) and postpartum (days 0-6 or 42-60). Trained phlebotomists will collect maternal and umbilical blood samples, centrifuge and obtain aliquots of serum, plasma and the buffy coat for storage. They will also measure HbA1C and collect a dried spot sample of whole blood. Maternal urine samples will also be collected and stored, alongside placenta, umbilical cord tissue and membrane samples, which will both be frozen and prepared for histology examination. Maternal and newborn stool (for microbiota) as well as paternal and newborn saliva samples (for DNA extraction) will also be collected. All samples will be stored at -80°C in the biobank in each of the three sites. These samples will be linked to numerous epidemiological and phenotypic data with unique study identification numbers.
IMPORTANCE OF THE STUDY: AMANHI biobank proves that biobanking is feasible to implement in LMICs, but recognises that biobank creation is only the first step in addressing current global challenges.

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Grants

  1. 001/World Health Organization

MeSH Term

Biological Specimen Banks
Biomarkers
Developing Countries
Feasibility Studies
Female
Humans
Pregnancy
Pregnancy Outcome
Prospective Studies

Chemicals

Biomarkers

Word Cloud

Created with Highcharts 10.0.0willsamplesAMANHIstudybiobankweekspregnancycollectalsooutcomesdevelopingpregnanciesdayspostpartumTrainedphenotypicepidemiologicaldataumbilicalbloodMaternalcollectedstorednewbornOBJECTIVES:aimsseekbiomarkerspredictorsimportantpregnancy-relatedestablishcountriesfutureresearchnewmethodstechnologiesbecomeavailableMETHODS:usingharmonisedprotocolsenrol3000womenearly8-19gestationpopulation-basedfollow-up42BangladeshPakistanTanzaniacollectiontakingplaceAugust2014June2016Urinetestsusedconfirmreportedsuspectedscreeningultrasoundtrainedsonographersaccuratelydatefieldworkersdetailedpregnantwomanfamilyscheduledhomevisitsenrolment24-2832-36&38+0-642-60phlebotomistsmaternalcentrifugeobtainaliquotsserumplasmabuffycoatstoragemeasureHbA1CdriedspotsamplewholeurinealongsideplacentacordtissuemembranefrozenpreparedhistologyexaminationstoolmicrobiotawellpaternalsalivaDNAextraction-80°CthreesiteslinkednumerousuniqueidentificationnumbersIMPORTANCEOFTHESTUDY:provesbiobankingfeasibleimplementLMICsrecognisescreationfirststepaddressingcurrentglobalchallengesUnderstandingbiologicalmechanismsunderlyingadversebirthcountries:protocolprospectivecohortbio-banking

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