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

ISRCTN	ISRCTN13687662
DOI	https://doi.org/10.1186/ISRCTN13687662
Secondary identifying numbers	SCC 1000

Submission date: 21/07/2005
Registration date: 15/08/2005
Last edited: 13/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Owens
Scientific

MRC Laboratories
P.O. Box 273
Fajara
-
Gambia

Phone	+220 9812617
Email	sowens@mrc.gm

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Periconceptual multi-micronutrient supplementation and placental function in rural Gambian women: a randomised controlled trial
Study acronym	PMMST
Study objectives	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(s)	Medical Research Council (MRC) and the Gambian Government Ethics Committee, 13/03/2006, reference numbers: SCC1000 and L2005.111, respectively
Health condition(s) or problem(s) studied	Fetal growth restriction
Intervention	UNICEF Maternal multi-micronutrient supplement (UNIMMAP) Placebo
Intervention type	Supplement
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 study start date	01/09/2005
Completion date	30/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	3000
Key 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
Key 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)
Date of first enrolment	01/09/2005
Date of final enrolment	30/03/2008

Locations

Countries of recruitment

Gambia

Study participating centre

MRC Laboratories

Fajara
-
Gambia

Sponsor information

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

London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Email	andrew.prentice@lshtm.ac.uk
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research council

Medical Research Council (UK) International Nutrition Group Core Funding
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2015		Yes	No