Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University College Dublin

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

21 Apr 2023 → 1 May 2025

Decision date (initial)

2024-05-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

NA- No funding granted, Dr O'Toole paid by hospital & as clinical fellow

External identifiers

EU CT number

2024-512064-61-00

EudraCT number

2022-001815-25

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine whether alternate day oral iron is noninferior to daily oral iron for the treatment of iron deficiency
anaemia by comparing haemoglobin level (Hb) between the
two arms after 4 weeks of therapy

Secondary objectives 1

1. Secondary objectives will be to compare compliance, tolerance and the incidence of GI side-effects in both groups, compare haemoglobin levels in both groups at term (37-42 weeks’ gestation) and compare obstetric and neonatal outcomes

Conditions and MedDRA coding

Iron deficiency anaemia in pregnancy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
2. Subjects must be aged 18 years or above at visit 1
3. Subjects will need to have a standard of English good enough to understand and read the information leaflet and consent form and communicate easily with the research team
4. A diagnosis of IDA as defined by Hb <10.5g/dL but not ≤7g/dl and a serum ferritin of <30µg/L
5. Singleton pregnancies
6. Gestational age of 14- 34 weeks’ gestation
7. A level of English high enough for informed consent and study participation

Exclusion criteria 9

1. Women <18 years of age
2. Allergy/sensitivity to Galfer or their ingredients
3. Subjects unable to provide written informed consent or who require an interpreter
4. Known haemoglobinopathy
5. Severe anaemia as defined by Hb ≤7g/dl
6. Subjects who have any other significant disease or disorder (including inflammatory bowel disease, haemochromatosis, haemoglobinopathy, any active inflammatory diseases, malabsorptive conditions) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
7. Any underlying medical disorder or medications that the research team feel would impact iron absorption eg. Hyperemesis, Coeliac’s disease, inflammatory bowel disease, anaemia of chronic disease or anaemia related to other causes (B12/Folate), previous bariatric surgery, active PUD, haemochromatosis
8. Multiple pregnancy
9. Not taking medications in a way which could potentially hinder the absorption of iron eg. PPIs, Antacids, levothyroxine all need to be taken separately to iron

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Hb levels at 4 weeks post IMP treatment

Secondary endpoints 5

1. Compliance as measured by objective pill count at 4 week assessment
2. Serum ferritin levels in both groups after 4 weeks treatment
3. Compliance as measured by questionnaire at 4 week assessment
4. Tolerance as measured by gastrointestinal symptom questionnaire at 4 week assessment
5. Obstetric and neonatal outcomes : o Delivery outcomes (livebirth, stillbirth, NND) o Mode of delivery (OVD, SVD, LSCS) o Rates and quantitation of primary PPH o Postnatal blood transfusion in the two weeks post-delivery (Y/N, if yes for RCC no. of units) o Postnatal iron transfusion in the two weeks post-delivery o Neonatal Intensive Care Unit admission (Y/N) o Apgar scores (at 1 and 5 minutes of life as standard) o Birth weights o Most recent Hb levels at term (37-42 wks gestation)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University College Dublin

Sponsor organisation

University College Dublin

Address

Catherine Mcauley Centre, 21 Nelson Street, Phibsborough 21 Nelson Street Phibsborough

City

Dublin 7

Postcode

DUB LIN7

Country

Ireland

Scientific contact point

Organisation

University College Dublin

Contact name

Gráinne O'Reilly

Public contact point

Organisation

University College Dublin

Contact name

Gráinne O'Reilly

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications