Entebbe Mother and Baby Study – Data at one year – User Guide

Persistent identifier

10.17037/DATA.128

Description

Dataset and supporting documentation collected as part of the Entebbe Mother and Baby Study (EMaBS), a clinical trial that investigated potential benefits of treating worm infections during pregnancy and early childhood. The dataset contains variables collected from mothers (at registration) and infants (when the child was one-year of age), including maternal age, education, parity and infection status (malaria, S. mansoni, hookworm, filariasis), and infant sex and immune responses (to HiB, diphtheria, Hepatitis B, pertussis, FHA, pertactin).

Data collection methods

Data was collected as part of a randomised control trial, ISRCTN32849447. Pregnant women who enrolled were randomised twice in this 2x2 factorial trial of albendazole and praziquantel to investigate the effect of maternal worms on infant vaccine response in urban Uganda.

Data analysis and preparation

All personal identifiable variables have been removed, including maternal date of birth, infant date of birth, home location and dates of vaccinations.

Geographic regions

Entebbe, Uganda

Key dates

Mothers were enrolled between April 2003 and November 2005. Data from infants was collected between April 2004 and May 2007.

Quality controls

Test results reviewed and anomalous results addressed by lab team.

Population

Mothers and children enrolled in the Entebbe Mother and Baby trial.

Privacy

This dataset contains no identifiable data.

Ethics

Ethical consent was granted for the original trial and for subsequent analysis from the following research ethics committees.

Organisation Ethics ID
Uganda Virus Research Institute GC/127/12/07/32
Uganda National Council for Science and Technology MV625
London School of Hygiene & Tropical Medicine 790, A340
Oxford Tropical Research Ethics Committee 39-12

Keywords

Pregnancy, vaccine, albendazole, praziquantel, schistosomiasis, hookworm, HiB, Diphtheria, Hepatitis B, Pertussis FHA, Pertactin

Language of written material

English

Project information

Project name Funder/sponsor Grant number Clinical Trial ID
The effect of worm infections during pregnancy on immunisations and infections in infants Wellcome Trust 079110 and 095778 ISRCTN32849447

Associated roles

Forename Surname Faculty / Dept Institution Role
Stephen Nash EPH / IDE London School of Hygiene & Tropical Medicine Contact Person, Data Manager
Alexander J. Mentzer Wellcome Trust Centre for Human Genetics University of Oxford Researcher
Swaib A. Lule   MRC/UVRI Uganda Research Unit on AIDS Researcher
Dennison Kizito   MRC/UVRI Uganda Research Unit on AIDS Researcher
Gaby Smits   Netherlands National Institute for Public Health and the Environment Researcher
Fiona R.M. van der Klis   Netherlands National Institute for Public Health and the Environment Researcher
Alison Elliott ITD / CR London School of Hygiene & Tropical Medicine Data Creator

File description

Filename Description Access status Licence
Emabs_public_data The EMaBs one-year dataset. Data is held in tab-delimited and Stata v14.2 format Open Creative Commons Attribution (CC BY)
Emabs_data_codebook A description of variables in the EMaBs one-year dataset Open Creative Commons Attribution (CC BY)
Emabs_oneyear_data_collection_form Form used to collect data at one year Open Creative Commons Attribution (CC BY)
Emabs_patient_info_consent Patient information and consent form - March 2003 Open Creative Commons Attribution (CC BY)
Emabs_Protocol Current trial protocol, with post data collection changes highlighted – Jan 2009 Open Creative Commons Attribution (CC BY)
Emabs_screening_form Form used to collect data from mothers at screening visit – March 2005 Open Creative Commons Attribution (CC BY)
0291-UserGuide User guide for EMaBS dataset (this document) Open Creative Commons Attribution (CC BY)