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

The Maternal and Newborn Health Core Outcome Set during Epidemics (MNH-EPI-COS) is a standardized set of outcomes designed to harmonize outcome selection and reporting in observational and experimental studies including pregnant and recently pregnant women, and infants. The core outcome set is for use in maternal and perinatal epidemiological studies, clinical studies assessing the safety and efficacy of preventive and therapeutic interventions, and post-authorization and surveillance in the context of ongoing and emerging epidemic threats.

The core outcome set was developed through a systematic review of observational and experimental studies, followed by a four-stage modified Delphi consensus process. This process involved a large international group of stakeholders who evaluated the relevance of outcomes through online surveys. Consensus meetings with a subgroup of stakeholders were then held to finalize the core outcome set.

The final core outcome set includes:

Seven main maternal outcomes:

  • pregnancy outcome
  • maternal death
  • suspected symptomatic infection
  • confirmed infection
  • severe disease
  • preterm delivery
  • mode of birth.

Eleven main neonatal outcomes:

  • neonatal death
  • suspected symptomatic infection
  • confirmed infection
  • severe disease
  • vertical transmission
  • low birth weight
  • prematurity
  • congenital disorders
  • respiratory support
  • skin-to-skin contact
  • breastfeeding.
 

Seven complementary maternal outcomes:

  • antepartum haemorrhage
  • postpartum haemorrhage
  • hypertensive disorders of pregnancy
  • maternal sepsis
  • admission to intensive care or special care units
  • respiratory support
  • depression or anxiety.

Four complementary neonatal outcomes:

  • admission to neonatal intensive care or special care units
  • respiratory failure
  • birth asphyxia
  • sepsis.

To support the uptake of the MNH-EPI-COS and facilitate data collection, processing, and reporting during epidemics, WHO has developed the MNH‑EPI‑COS data collection and analysis toolkit.

The MNH‑EPI‑COS toolkit supports the integration of the MNH-EPI-COS across diverse contexts, enabling timely and accurate recording and reporting of core outcomes. The toolkit brings together a reference guide, generic case report forms, REDCap template modules, statistical R scripts, dummy tables, a data dictionary, and a training package to support consistent data collection, processing, and reporting across diverse settings.

It was developed using a mixed‑methods evaluation with research teams in five countries. Teams received standardized training and then piloted all toolkit components using retrospective datasets from previous outbreaks.

Key resources

Pingray V, Klein K, Alonso JP, Belizan M, Babinska M, et al. A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus. EClinicalMedicine. 2025 Jan 15;80:103025. doi: 10.1016/j.eclinm.2024.103025.

Klein K, Alonso JP, Berrueta M, Oladapo OT, Bonet M, Belizán M, Pingray V. Acceptability and perceived barriers to adoption of the core outcome set for maternal and neonatal health research and surveillance during emerging and ongoing epidemic threats (MNH-EPI-COS): An online survey. PLOS Glob Public Health. 2025 Nov 25;5(11):e0005474. doi: 10.1371/journal.pgph.

Mazzoni A, Berrueta M, Pingray V, Babinska M, Nigri C, et al. A systematic review of maternal and perinatal health outcomes in the context of epidemic threats: towards the development of a core outcome set. Matern Health Neonatol Perinatol. 2025 Aug 11;11(1):23. doi: 10.1186/s40748-025-00215-w.