PANDA - Dose Study, v1.0
Research type
Research Study
Full title
A pilot clinical trial to test the acceptability and feasibility of different doses of oral iron supplementation to prevent maternal anaemia
IRAS ID
301769
Contact name
Simon Stanworth
Contact email
Sponsor organisation
NHS Blood and Transplant
Eudract number
2021-003316-51
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Research Summary
Around a third of UK pregnant women develop anaemia (reduced numbers of red blood cells) caused by lack of iron.
Anaemia may mean that women experience general health problems such as excessive tiredness. Severe anaemia during pregnancy might increase the risk of a baby being stillborn, born early, or born small (with a low birthweight). It may also increase the risk of blood loss during childbirth and affect a baby’s development. We know that treating anaemia after it develops does not reduce all the risks.This study describes the second project within a larger research programme, called ‘Primary prevention of maternal ANaemia to avoid preterm Delivery and other Adverse outcomes (PANDA)’.
The aim of PANDA is to find out whether we can prevent anaemia in the first place by giving iron tablets, and improve well-being of mother and baby.In this study, we aim to test three oral iron schedules (once daily dose vs alternate-daily dose vs three times a week dose) in order to determine the best dose of oral-iron supplementation for preventing anaemia with minimal adverse effects. We will count how many tablets are taken by a mother, and use a validated questionnaire to ask about adherence.
We will see how different doses of oral iron affect changes in haemoglobin during pregnancy. We will record possible side-effects that may be due to taking iron. We will also record how many mothers completed the trial visits and data collection.At a later stage in this study, we will apply for an amendment, to test and refine
a behavioural intervention developed from the first project of the PANDA programme, to help women to adhere to oral iron supplementation.Overall, the findings from this study will tell us about the best dose of oral iron to be tested in a large national trial of oral iron supplementation.
Summary of results
: Overall, 709 women were approached to take part in the trial. Of the 300 participants, 98 were randomised to the daily arm, 99 to the alternate arm and 103 were randomised to the three times a week arm.
There were 4 main outcomes of interest relating to; adherence, maintenance of maternal haemoglobin, side effects and protocol compliance:
* Adherence:
It was pre-specified that the tablet count data would be the main measure of adherence.
o This was measured using tablet counts and Medication Event Monitoring System (MEMS) caps (for half of the participants). The average proportion of tablets taken as expected per participant was 82.5% overall (72.3% for the daily arm, 89.6% for the alternate arm and 84.5% for the three times a week arm). Based on tablet count, 57.0% of participants were considered to be adherent (they returned the expected number of tablets +/-15%). This rate was 47.1% in the daily arm, 62.0% for the alternate and 60.8% for the three times a week arm.
o MEMS adherence rates were based on the half of the participants who were given a MEMS cap. These were lower than the tablet count adherence rates; 39.2% overall, 41.7% in the daily arm, 42.9% in the alternate arm and 34.2% in the three times a week arm. For MEMS adherence, a participant was classed as adherent if the percentage of doses taken as expected was at least 85%.* Change in haemoglobin:
o The average change in haemoglobin between randomisation and 28 weeks was 10.9g/L in the daily arm, 12.3g/L in the alternate arm and 12.4g/L in the three times a week arm.
o Ninety-four percent of participants maintained haemoglobin levels above diagnostic thresholds at 28 weeks: 95.7% in the daily arm, 91.3% in the alternate arm and 96.3% in the three times a week arm.
* Side effects:
o Side effects data varied across the arms. Black stools at 16 weeks were reported for 54.3% in the daily arm, 34.1% in the alternate arm and 35.6% in the three times a week arm.
o Constipation at 16 weeks was reported for 49.4% in the daily arm, 35.6% in the alternate arm and 36.0% and three times a week arm.
o Indigestion at 24 weeks was reported by 17.8% in the daily arm, 29.3% in the alternate arm and 24.1% in the three times a week arm. Heartburn at 24 weeks was reported by 45.1% in the daily arm, 54.1% in the alternate arm and 40.5% in the three times a week arm.
* Protocol compliance:
o Overall, 54.0% of participants completed the trial ( 53.1% in the daily arm, 57.6% in the alternate arm and 51.5% in the three times a week arm).
o Tablet return data were completed for 76.0% of participants.
o There were 23 participants (7.7%) who withdrew completely from the trial and 41 (13.7%) withdrew from treatment.
o Twenty participants were reported as lost to follow up, but delivery data were obtained for 16 of these.REC name
Wales REC 5
REC reference
21/WA/0247
Date of REC Opinion
13 Sep 2021
REC opinion
Further Information Favourable Opinion