Dataset Information

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

ABSTRACT: 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.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.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.

SUBMITTER: AMANHI (Alliance for Maternal and Newborn Health Improvement) Bio–banking Study group)

PROVIDER: S-EPMC5665675 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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

Baqui Abdullah H AH Khanam Rasheda R Rahman Mohammad Sayedur MS Ahmed Aziz A Rahman Hasna Hena HH Moin Mamun Ibne MI Ahmed Salahuddin S Jehan Fyezah F Nisar Imran I Hussain Atiya A Ilyas Muhammad M Hotwani Aneeta A Sajid Muhammad M Qureshi Shahida S Zaidi Anita A Sazawal Sunil S Ali Said M SM Deb Saikat S Juma Mohammed Hamad MH Dhingra Usha U Dutta Arup A Ame Shaali Makame SM Hayward Caroline C Rudan Igor I Zangenberg Mike M Russell Donna D Yoshida Sachiyo S Polašek Ozren O Manu Alexander A Bahl Rajiv R

Journal of global health 20171201 2

<h4>Objectives</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 29163938

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Project description:Study questionWhat demographic and baseline characteristics are predictive of adherence to reproductive medicine clinical trial protocols, live birth or participation in genetic studies?Summary answerRace, BMI and lower income are associated with likelihood of non-adherent to reproductive medicine clinical trial protocols, while race influences collection of biological samples and non-adherent to study protocols is associated with lower probability of live birth.What is known alreadyAlthough aspects of adherence to study protocol have previously been evaluated as individual factors in infertile women, the factors that affect overall non-adherent to study protocol have not been previously evaluated.Study design, size, durationA secondary data analysis of 1650 participants from two prospective multicenter, double-blind controlled studies was carried out: Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS).Participants/materials, setting, methodsThe participants were women aged 18-40 years old with either polycystic ovary syndrome (PCOS) with ovulatory dysfunction in combination with either hyperandrogenemia and/or polycystic ovarian morphology (PPCOS II), or regular ovulatory cycles with unexplained infertility (AMIGOS). The study was carried out in 14 clinical sites in the USA. Non-adherence to clinical trial protocol was chosen as the primary outcome for this analysis. To evaluate whether demographic and baseline characteristics were predictive of adherence to study protocols, live birth or participation in blood sampling for DNA and repository, and pregnancy registry, these putative factors were compared between the outcome measures. Logistic regression was used to establish a prediction model using the putative predictors introduced above.Main results and the role of chanceWomen who self-identified as African American or Asian and those with higher BMI and lower household income were less likely to adhere to protocol. Non-adherence to the study protocol was associated with a lower probability of live birth (odds ratio: 0.180, 95% CI: 0.120, 0.272, P < 0.001). African Americans or Asians were less likely to participate in optional study DNA collection compared to Whites. Participants who were African American or with high annual income or from the Southwest sites or had PCOS were less likely to participate in the blood repository studies.Limitations, reasons for cautionRace and ethnicity were self-reported and such self-classification to strict race and ethnicity may not always be representative of a whole racial or ethnic group. This study included two US multicenter trials and therefore the findings may not be extrapolated to international trials.Wider implications of the findingsIdentification of populations with low participation is an important initial step, as further investigation can develop specific measures to improve adherence to study protocols and participation in biospecimen banking and thereby extend the representativeness of reproductive medicine clinical trial findings.Study funding/competing interest(s)Supported by NIH Eunice Kennedy Shriver NICHD Grants: U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936, U10HD055925, PPCOSII: U10 HD27049, U10 HD38992, U10 HD055925, U10 HD39005, U10 HD38998, U10 HD055936, U10 HD055942, U10 HD055944; Clinical Reproductive Endocrine Scientist Training Program (CREST): R25HD075737. Outside this study, M.P.D. received NIH/NIHCD research grant and R.S.L. received research grant from Ferring and was consultant for Bayer, Kindex, Odega, Millendo and AbbVie.Trial registration numberClinicalTrials.gov number: NCT00719186; NCT01044862.

Dataset Information

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

Publications

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

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