A study of the induction and resolution of hypophosphatemia following intravenous iron (ferric carboxymaltose) treatment of anaemic Malawian pregnant women in their second trimester

Phase 4

• Conditions: Anaemia; Iron deficiency; Hypophosphatemia; Blood - Anaemia; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12623000787684
• Lead Sponsor: Training and Research Unit of Excellence (TRUE), Malawi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-19
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

Participants meeting the following criteria will be included in the trial:
1. Confirmed singleton pregnancy in the second trimester (13-26) weeks of gestation, dated by ultrasound
2. Moderate to severe anaemia as measured by capillary haemoglobin on HemoCue instrument, not requiring an immediate blood transfusion (Hb <10g/dl)
3. Negative malaria parasitaemia measured by rapid diagnostic test
4. Currently afebrile with no evidence of septicaemia
5. Written informed consent (including assent if <18 years old)

Exclusion Criteria

1. Previous enrolment in REVAMP trial, REVAMP-TT trial or REVAMP-OBS trial
2. Actively participating in another interventional trial
3. Known hypersensitivity to the study drugs
4. Clinical symptoms of malaria or other infection
5. Any condition requiring hospitalisation in the next seven days of serious concomitant illness
6. Known history of sickle cell or sickle-haemoglobin C anaemia
7. Clinically low haemoglobin level requiring a blood transfusion (usually Hb<5g/dl)
8. Preeclampsia
9. HIV positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The nadir serum phosphate concentration following a single treatment dose of intravenous ferric carboxymaltose[The lowest serum phosphate concentration will be determined from sampling at 13 time points following the administration of ferric carboxymaltose. The time points are 3 days, 7 days, 10 days, 14 days, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks post-intervention, as well as 36 weeks’ gestation and delivery. ]