Effect of tempe and vitamin C rich fruit supplementation during pregnancy on iron status and pregnancy outcomes

Completed

• Conditions: Anaemia during pregnancy; Pregnancy and Childbirth; Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium

• Registration Number: ISRCTN13994081
• Lead Sponsor: estle Foundation (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. Pregnant women, gestation 12-20 weeks
2. Age 15-49 years
3. No existing severe maternal illness

Exclusion Criteria

1. Suffer from chronic disease
2. In medication/antibiotic treatment
3. Do not sign inform consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal iron status at gestation 12-20 week: <br>1. Haemoglobin<br>2. Ferritin<br>3. Soluble transferrin receptors

Secondary Outcome Measures

Name	Time	Method
1. Infectious status at gestation 12-20 weeks and 32-36 weeks: <br>1.1. C-reactive protein<br>1.2. A-1 acid glycoprotein<br>2. Helminth infestation (hookworms, A.lumbricoides, T.trichiura) measured quantitatively (eggs per gram) at gestation 12-20 weeks and 32-36 weeks<br>3. Gestational age calculated from date of last menstruation and palpation<br>4. Weight gain of pregnant women and birth weight of infant will be measured with electronic weighing scale<br>5. Length of infant will be measured with length board<br>6. Complication deliveries/fetal loss will be measured with verbal autopsy interviews, less than 3 days after delivery