A clinical trial to find out the optimal oral iron dosing schedule for the prevention of anaemia in pregnant women (PANDA-Dose study)

A pilot clinical trial to test the acceptability and feasibility of different doses of oral iron supplementation to prevent maternal anaemia - PANDA-Dose Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12911644

Enrollment

300

Registered

2023-04-27

Start date

2022-01-17

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron supplementation in pregnant women Pregnancy and Childbirth

Interventions

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 fer

Eligibility

Sex/Gender

Female

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Adherence is measured using the following methods at 28 weeks: 1.1 Proportion of participants considered adherent to their dose schedule based on a count of returned tablets 1.2 Medication Adhesion Report Scale-5 (MARS-5) adherence questionnaire score 1.3 In those women that receive a Medication Event Monitoring System (MEMS) cap, the proportion of planned doses taken as scheduled according to the MEMS cap 2. Maternal haemoglobin concentration in pregnancy measured using blood tests between randomisation and 28 weeks 3. Types and frequency of symptoms reported by women which may be associated with iron supplementation at baseline remote visits assessments at Weeks 16 and 24 gestation (+/- two weeks), and at Week 28 gestation (+/- two weeks) 4. The following recruitment and protocol compliance variables measured using medical/study records and screening log at the end of the study 4.1 Proportion of approached women who consented. 4.2 Proportion of participants who completed the trial visits and data collection. 4.3 Use of iron-containing supplements 5. Fidelity, feasibility and acceptability of the behavioural intervention measured using the following methods throughout the study : 5.1 Audio recordings and completed checklists of delivered intervention components and website usage 5.2 Survey and interview data assessing pregnant women and healthcare professional views on feasibility and acceptability	—

Measure

Time frame

1. Adherence is measured using the following methods at 28 weeks: 1.1 Proportion of participants considered adherent to their dose schedule based on a count of returned tablets 1.2 Medication Adhesion Report Scale-5 (MARS-5) adherence questionnaire score 1.3 In those women that receive a Medication Event Monitoring System (MEMS) cap, the proportion of planned doses taken as scheduled according to the MEMS cap 2. Maternal haemoglobin concentration in pregnancy measured using blood tests between randomisation and 28 weeks 3. Types and frequency of symptoms reported by women which may be associated with iron supplementation at baseline remote visits assessments at Weeks 16 and 24 gestation (+/- two weeks), and at Week 28 gestation (+/- two weeks) 4. The following recruitment and protocol compliance variables measured using medical/study records and screening log at the end of the study 4.1 Proportion of approached women who consented. 4.2 Proportion of participants who completed the trial visits and data collection. 4.3 Use of iron-containing supplements 5. Fidelity, feasibility and acceptability of the behavioural intervention measured using the following methods throughout the study : 5.1 Audio recordings and completed checklists of delivered intervention components and website usage 5.2 Survey and interview data assessing pregnant women and healthcare professional views on feasibility and acceptability

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Contacts

Public ContactTom Holmes

panda@nhsbt.nhs.ukNone available

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026