Research study tools and resources

Antiretrovirals in pregnancy research toolkit

This open access toolkit was developed by the WHO HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group. It represents a strategic response to the Call to Action for a new framework to accelerate inclusion of pregnant and lactating people in pre-licensure clinical trials. This “living” toolkit provides access to a repository of resources, including guidance on standardised measurements and definitions, study protocols, conceptual frameworks and more.

Global Alignment on Immunisation Safety Assessment in Pregnancy (GAIA) Guidance & Study Design Documents and Case Definitions

The GAIA project, coordinated by the Brighton Collaboration and funded by the Bill & Melinda Gates Foundation, was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC.

Core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS)

This COS was developed using a modified Delphi approach and aims to standardise the reporting of maternal and neonatal outcomes in studies related to infectious disease outbreaks. It forms a key component of WHO’s Roadmap for research on maternal and perinatal health in the context of epidemic threats.

ConcePTION: core data elements for pregnancy pharmacovigilance

Recommendations on selecting, identifying and establishing core evidence elements for pregnancy pharmacovigilance developed by the IMI ConcePTION project, plus a framework of 98 individual data elements (searchable list).

Swedish Perinatal Core Outcome Set

A Core Outcome Set for short-term perinatal (fetal and neonatal) outcomes developed through Delphi consensus to guide research and quality assurance of management of labour and delivery at or near term.

INTERGROWTH-21st standards and tools

The INTERGROWTH-21st Project set out to create prescriptive standards of fetal growth, newborn size and early child neurodevelopment to complement the existing WHO Child Growth Standards. Its resulting standards are globally-validated and cover fetal growth, newborn size and body composition, 2-year neurodevelopmental (cognition, motor, language and behaviour) outcomes and postnatal growth of preterm infants. Practical training resources also provided.

Core outcome set for studies of pregnant women with multimorbidity

A core outcome set for studies of pregnant people with multimorbidity, with 11 outcomes included in the final COS (5 maternal and 6 child).

Generic qualitative study protocol on issues related to pregnancy, pregnancy prevention and abortion in the context of the COVID-19 pandemic.

This is a standardised protocol for prospective qualitative research using semi-structured interviews, developed to facilitate assessment of reproductive health issues during and after the COVID-19 pandemic in low and middle income countries.

Edinburgh Reproductive Tissue BioBank (ERTBB)

Biobank of tissue samples and matched medical data available in anonymised form for researchers working to improve maternal and fetal health on projects with existing ethical approval from an appropriate ethics committee.

Building Blocks of Pregnancy Biobank

Long-standing biobank, with longitudinal sample collection during pregnancy, including labour and delivery. Prospectively collected samples are linked to pregnancy outcomes, with over 3,000 participants and over 55,000 samples to date. BBPB is a resource available for IU-affiliated researchers and external researchers conducting pregnancy-related research, including topics such as preterm birth, gestational diabetes mellitus and preeclampsia.

ConcePTION biobank of breast milk for clinical lactation studies

These resources from the IMI ConcePTION project include protocols for demonstration studies to investigate how amoxicillin, levocetirizine, metformin, prednisolone and venlafaxine transfer from mother to baby during lactation, as well as details of validated and standardized methods.

Zika virus infection in pregnancy: a protocol for the joint analysis of the prospective cohort studies of the ZIKAlliance, Zika PLAN and ZIKAction consortia

This protocol sets out the approach to a joint analyses of data from multiple sites following similar protocols with harmonised definitions of clinical and laboratory outcomes in order to estimate risk of adverse outcomes in the fetus and infant following maternal ZIKV infection in pregnancy, estimate prevalence of markers of congenital infection and assess associations with timing and severity of maternal infection.

Vertical transmission of Zika virus and its outcomes: a Bayesian synthesis of prospective studies

In this paper, Bayesian latent class analysis was used to synthesise data from multiple studies with different approaches (including different diagnostic tests), outcome definitions and comparison groups.

Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies (PREVENT) guidance

The PREVENT guidance presents a roadmap for the inclusion of pregnant people in vaccine development and deployment in an ethically responsible and respectful manner. It was produced by a multidisciplinary expert working group, and includes 22 recommendations across three domains – public health preparedness, R&D and vaccine delivery.

Pregnant women & the Zika Virus vaccine research agenda: ethics guidance on priorities, inclusion, and evidence generation

This guidance was published in 2017 in response to the Zika Virus outbreaks in Latin America and the Caribbean at that time.