ISRCTN - ISRCTN13687662: Periconceptual multi-micronutrient supplementation and placental function in rural Gambian women

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Owens

ORCID ID

Contact details

MRC Laboratories
P.O. Box 273
Fajara
-
Gambia
+220 9812617
sowens@mrc.gm

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCC 1000

Study information

Scientific title

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

Acronym

PMMST

Study hypothesis

Improved maternal micronutrient status prior to conception and during early pregnancy results in improved placental growth and functional parameters, relevant to fetal growth and physiological development.

Ethics approval

Medical Research Council (MRC) and the Gambian Government Ethics Committee, 13/03/2006, reference numbers: SCC1000 and L2005.111, respectively

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fetal growth restriction

Intervention

UNICEF Maternal multi-micronutrient supplement (UNIMMAP)
Placebo

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/09/2005

Overall trial end date

30/03/2008

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3000

Participant 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)

Recruitment start date

01/09/2005

Recruitment end date

30/03/2008

Locations

Countries of recruitment

Gambia

Trial participating centre

MRC Laboratories
Fajara
-
Gambia

Sponsor information

Organisation

Medical Research Council (MRC) International Nutrition Group (UK)

Sponsor details

London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
-
andrew.prentice@lshtm.ac.uk