Title (1)	Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial
Trial registration {2a and 2b}.	European Union Drug Regulating Authorities Clinical Trials Database: 2017-000776-29 ClinicalTrials.gov: NCT03188445.
Protocol version {3}	Trial ID: P-Monofer-PREG-01 version 6, amendment 5, date of protocol: 4 September 2019 (accepted by the Scientific Ethics Committees on 13 November 2019)
Funding {4}	The trial is fully funded and sponsored by Pharmacosmos A/S, Roervangsvej 30, 4300 Holbaek, Denmark. The trial participants are not compensated financially for participating in the trail.
Author details {5a}	1 Department of Obstetrics and Gynaecology, Amager-Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark 2 Pharmacosmos A/S, Roervangsvej 30, 4300 Holbaek, Denmark 3 Laboratory of Neurobiology, Department of Health Science and Technology, Aalborg University, Fredrik Bajers Vej 7, 9220 Aalborg, Denmark 4 University of Copenhagen, Department of Health sciences, Blegdamsvej 3B, 2200 Copenhagen, Denmark 5 Fertility Clinic, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark
Name and contact information for the trial sponsor {5b}	Pharmacosmos A/S, Roervangsvej 30, 4300 Holbaek, Denmark. Tel.: +45 59 48 59 59
Role of sponsor {5c}	Pharmacosmos A/S was the GCP-sponsor and funded the study. Pharmacosmos A/S took responsibility for and coordinated data collection and management and will take responsibility for and coordinate analysis and interpretation of data and writing of the clinical study report. Pharmacosmos A/S was involved in preparation of this manuscript. Pharmacosmos cannot prohibit the trial center or investigator from publishing trial data.