Plans for assessment and collection of outcomes {18a}
PPH, death, CRF
HYPERTENSIVE DISEASE, CRF, PLACENTAL ABNORMALITY, ANTEPARTUM, HAEMORRHAGE, ADVERSE EVENT
The local trial staff will collect consent, baseline, outcome, and adverse event data and send them to the LSHTM CTU Global Health Trials Group by entering them into the online trial database. All staff authorised to collect trial data will be trained in data collection procedures and GCP. The staff will first enter trial data onto paper case report forms (CRF) and then the trial database to allow easier data control. After completing the consent procedure, an entry form will be used to collect baseline data including the woman’s age, gestational age, parity, recent Hb or PCV if known, multiple pregnancy, planned route of birth, previous PPH, hypertensive disease, placental abnormality, antepartum haemorrhage, and any other PPH risk factors. We will also collect the date and time of randomisation and IM injection sites. We will follow up participants until discharge, death, or the end of the postnatal period (42 days), whichever occurs first, and trained staff will record outcome data onto an outcome form.