The EN-BIRTH study aims to validate selected newborn and maternal indicators for routine facility-based tracking of coverage and quality of care for use at district, national and global levels. This is an observational study of >22,000 facility births in three countries (Tanzania, Bangladesh and Nepal). Direct clinical observation are compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, essential newborn care, neonatal resuscitation and Kangaroo Mother Care. Indicators for neonatal infection management and antenatal corticosteroid administration, will be validated using inpatient records because they cannot be easily observed. Trained clinical observers in labour/delivery ward, operation theatre, and Kangaroo Mother Care ward/areas collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (i.e. true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be evaluated by data flow assessments, quantitative and qualitative analyses.