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

Periconceptual multi-micronutrient supplementation and placental function in rural Gambian women: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13687662

Enrollment

3000

Registered

2005-08-15

Start date

2005-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal growth restriction Neonatal Diseases Fetal growth restriction

Interventions

UNICEF Maternal multi-micronutrient supplement (UNIMMAP) Placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026