Information Hub
The PIPELINE Information Hub is a comprehensive resource centre dedicated to the safe, ethical, and effective inclusion of pregnant individuals and children in clinical research. We provide researchers, clinicians, and ethicists with the tools necessary to move from protecting through exclusion to protecting through evidence.
PIPELINE digest
Below is a curated list of clinical studies and peer-reviewed publications focused on the inclusion of pregnant individuals and infants in research.
From clinical data and infant populations to key publications highlighting the need for their inclusion, these resources provide the evidence needed to bridge the gap in maternal and infant health research.
The MELODY Study
The MELODY study evaluated the efficacy of Nirsevimab, a long-acting monoclonal antibody. Unlike a traditional vaccine that teaches the body to make its own antibodies, Nirsevimab provides “ready-made” passive immunity.
- Target: Healthy infants entering their first RSV season.
- Key Findings: A single dose reduced RSV-associated lower respiratory tract infections (LRTI) by approximately 75%.
- Impact: Significant reduction in hospitalisations and emergency department visits.
Supporting Evidence
- Nirsevimab Effectiveness: Recent real-world data and meta-analyses confirm its role in drastically cutting hospitalizations for RSV bronchiolitis.
Read the research:
More on ClinicalTrials.gov
The MATISSE Study
The MATISSE study explored the efficacy of a bivalent RSV prefusion F protein-based vaccine administered during pregnancy to protect the newborn from birth.
- Mechanism: Administered to mothers between the 24th and 36th week of gestation. The mother develops antibodies that are transferred across the placenta to the fetus.
- Efficacy: Found to be 81.8% effective in preventing severe RSV-related respiratory disease within the first 90 days of life.
- Durability: Protection remained high through the infant’s first six months.
Supporting Evidence
Research continues to monitor the safety and immunogenicity of maternal vaccines, ensuring optimal outcomes for both mother and child, including the monitoring of preterm birth rates.
Read the research:
More on ClinicalTrials.gov
Useful Publications
Challenges of involving pregnant individuals in clinical research
- Historical Factors
Legacy of catastrophic events such as the Thalidomide tragedy created a long-lasting culture of caution in research involving pregnancy. This historical context still influences regulatory and ethical frameworks today.
(Ref: Bencheva V et al., 2024; https://doi.org/10.1016/j.cct.2022.106806)
- Ethical Factors
Fear of teratogenic or fetal harm from experimental drugs, difficulty predicting risk/benefit ratios for both mother and fetus, and medical-legal liability concerns in case of adverse outcomes (e.g., malformations, preterm birth). Consent issues are particularly complex: newborns cannot provide consent, and proxy consent raises ethical debates.
(Ref: Moayad L et al., The Lancet, 2024; ACOG Committee Statement, 2024)
- Regulatory Factors
Restrictive interpretation of “minimal risk” and “direct benefit” requirements often limits trial design. Approval processes for vulnerable populations are complex and time-consuming, discouraging sponsors from pursuing these studies.
(Ref: Moayad L et al., The Lancet, 2024)
- Economic Factors
Low perceived profitability due to smaller population size compared to adults. Trials are more expensive because of intensive monitoring and safety requirements. Pharmaceutical companies are often reluctant to invest in specialized formulations for neonates, adding further cost barriers.
(Ref: Shankar M et al., PLoS Med, 2024)
- Scientific & Methodological Factors
Pregnancy alters pharmacokinetics and pharmacodynamics (blood volume, metabolism, renal clearance), requiring different dosages and complex modeling. Variability across trimesters means larger and more stratified sample sizes. For infants, hepatic and renal immaturity complicates dose definition, and customized formulations (e.g., syrups, drops) increase costs and complexity.
(Ref: Shaikh H et al., JAMA Netw Open, 2024; Bencheva V et al., Syst Rev, 2024)
- Sociocultural Factors
Reluctance of women and families to participate due to fear, mistrust, and cultural norms influencing decision-making and autonomy. These factors often intersect with socioeconomic barriers, further reducing enrollment rates.
(Ref: Shankar M et al., PLoS Med, 2024)
Clinical data for pregnancy and infant health research
Access the Central Data Repository (CDR) of the Cohort Coordination Board (CCB), an online database of European infectious disease clinical research studies, including pregnancy and infant health research..
The CDR is a collaborative effort of the EU-funded projects VERDI and CoMeCT which addresses the urgent need for efficient data management in the face of evolving infectious disease challenges. The CDR aims to minimise research duplication and accelerate the identification of key research infrastructures across Europe.
Access the Central Data Repository
Pregnancy Research Toolkits
Our podcast features in-depth conversations with leading researchers and clinicians. We explore the real-world challenges of trial design and the innovative solutions being used to close the evidence gap for pregnant populations and children.
WHO Antiretrovirals in Pregnancy Research Toolkit
Guidance and resources to accelerate the inclusion of pregnant and breastfeeding populations in research on treatment and prevention of HIV, viral hepatitis and STIs.
This toolkit presents 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.
VERDI Pregnancy Toolkit
This Pregnancy Research Toolkit, developed through the EU-funded VERDI project, addresses this gap by offering a set of tools, guidance and resources to strengthen research on pregnancy in the context of epidemic and pandemic preparedness.
Designed for researchers and study teams, the Toolkit serves as a “one stop shop” to ensure pregnancy is systematically included in global epidemic research and preparedness efforts.
PIPELINE Podcast
PIPELINE Virtual Learning Centre (VLC)
From foundational ethics to advanced protocol design, our selection of training courses is designed to equip your team with actionable skills. These courses cover the regulatory requirements and practical steps needed to conduct safe and ethical research.
All suggested courses are in English and the majority are accessible online.
View PIPELINE’S list of curated courses.
