Does intravenous iron administration in pregnancy change blood vessel and heart function?

Not Applicable

Recruiting

• Conditions: iron deficiency in pregnancy; iron deficiency anaemia in pregnancy; Cardiovascular - Normal development and function of the cardiovascular system; Blood - Anaemia; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12616000173493
• Lead Sponsor: yell McEwin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

28 - 38 weeks of gestation
Singleton pregnancy
Booked for iron infusion with FCM at Lyell McEwin Hospital

Control:
28 - 38 weeks of gestation
Singleton pregnancy
Not iron deficient
Haemoglobin >/= 110 g/L

Exclusion Criteria

Skin condition (e.g. psoriasis) on the location where skin doppler studies would take place
Blood pressure >140/>90mmHg
Preexisting cardiovascular disease
Diabetes Mellitus including gestational diabetes
Depression
Obesity (BMI >30 at booking / prior to pregnancy)
Inability to provide informed consent
Non-English speaking

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in skin microvascular reactivity as assessed by Laser Doppler flowmetry in response to:<br>1. Iontophoresis of acetylcholine and sodium nitroprusside<br>2. Local heating <br>3. Post-occlusive reactive hyperemia[In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.];Change in cardiac hemodynamics as measured by USCOM:<br>1. cardiac output<br>2. stroke volume<br>3. total peripheral resistance<br>4. inotropy index[In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.]

Secondary Outcome Measures

Name	Time	Method
Change in central and peripheral vascular function as measured by arteriograph:<br>1. central and brachial blood pressure<br>2. pulse wave velocity<br>3. augmentation index.[In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.];Change in retinal vascular diameter measured using retinal photography:<br>1. central retinal venular equivalents (CRVE)<br>2. central retinal arteriolar equivalents (CRAE)[In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.]