Periconceptual multi-micronutrient supplementation and placental function in rural Gambian wome

Completed

Conditions: Fetal growth restriction
Neonatal Diseases

Registration Number: ISRCTN13687662

Lead Sponsor: Medical Research Council (MRC) International Nutrition Group (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 3000

Inclusion Criteria

Women of reproductive age (17 years to 45 years) living in West Kiang, The Gambia.
The age inclusion criteria was previously 15 to 45 years of age, amendment date: 20/03/2006

Exclusion Criteria

1. Women known to be already pregnant
2. Women breastfeeding infants less than 1 year of age
3. Women found to be severely anaemic at recruitment (haemoglobin concentration <7 g/dl)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The ratio of plasminogen activator inhibitor-1 (PAI-1) to plasminogen activator inhibitor-2 (PAI-2) at 20 weeks gestation<br>2. Placental doppler flows at 20 weeks<br>3. Placental transfer of pathogen specific IgG at delivery<br><br>Primary outcomes amended from the following on 20/03/2006:<br>1. Placental volume at 20 weeks gestation<br>2. Placental doppler flows at 20 weeks<br>3. Placental transfer of pathogen specific IgG at delivery

Secondary Outcome Measures

Name	Time	Method
1. Maternal serum human chorionic gonadotropin (hCG) and human placental lactogenic (hPL) concentration at 20 weeks<br>2. The ratio of PAI-1 to PAI-2 at 30 weeks, and at delivery<br>3. Placental doppler waveforms at 30 weeks<br>4. Change in maternal haematological status from baseline to 20 and 30 weeks gestation, and at delivery<br>5. Change in maternal micronutrient status from baseline to 20 and 30 weeks gestation, and at delivery<br>6. Fetal anthropometry at 20, 30 weeks and at delivery<br>7. Placental weight at delivery <br><br>Secondary outcomes amended from the following as of 20/03/2006:<br>1. Placental endocrine function (hCG; hPL) at 20 weeks<br>2. Placental volume at 30 weeks<br>3. Placental doppler waveforms at 30 weeks<br>4. Fetal anthropometry at 20, 30 weeks and at delivery<br>5. Placental weight at delivery<br>6. Placental transport function (essential amino acids) at delivery