A pilot clinical trial to test the acceptability and feasibility of different doses of oral iron supplementation to prevent maternal anaemia - PANDA-Dose Study
Iron supplementation in pregnant women
Overall design This study is an open-labelled randomised trial. Participants will be randomised to one of its three dose arms, 200 mg ferrous sulfate daily (containing 65mg elemental iron), 200 mg ferrous sulfate on alternate days and 200 mg ferrous sulfate three times per week (e.g. Mon/Wed/Fri). Participant identification and recruitment Healthy non-anaemic pregnant women will be recruited initially from two sites (The Royal Wolverhampton NHS Trust and Oxford University Hospitals NHS Foundation Trust). A third site may be added if required. Information about the study will be provided to women at their first contact with the maternity services. This would usually be given to them by their community midwives but could also be at their antenatal clinics, ultrasound dating and early pregnancy assessment units. We will also display information about the trial in antenatal clinics and early pregnancy assessment units and on public-facing research pages for each maternity unit, PPI groups, social media and trial website. Interested participants will be able to contact the local research team directly. Potential participants may also be identified and approached by their care team (or local research team if different) such as through hospital clinic lists and other databases, and they will be contacted by phone and sent the trial information pack. A screening log will be maintained which records information about the women approached including age, gestational week, parity, ethnicity, numbers declined and reason for the decline, ineligible and reason for ineligibility, consented and eligible. Randomisation After signing the informed consent form and completing eligibility checks at the baseline visit, participants will be randomised to one of the three-dose arms in a 1:1:1 ratio and will also be randomised 1:1 to whether they will receive a Medication Event Monitoring System (MEMS) cap. The MEMS cap automatically records the date and time of every occasion the bott
1. Healthy non-anaemic pregnant women of all parities (haemoglobin concentration (Hb) > = 110 g/l) at booking or screening. 2. 13 weeks + 6 days gestation or less 3. Age 18 and above 4. Able to give informed consent and willing to fulfil trial requirements
Women with the following conditions will be excluded: 1. Known haemoglobinopathies 2. Anaemia of any type, defined by BSH guidelines 3. Severe gastrointestinal disease, affecting tolerability of oral iron 4. Allergies to iron 5. Multiple pregnancies, given the higher iron demands 6. Known haemochromatosis 7. Recent red cell transfusion, within 1 month