Short summary

The BCG-vaccine (tuberculosis vaccine) lowers mortality when given at birth in low-income countries. New research has shown that the effect of the BCG-vaccine at birth is dependant on the mothers BCG-vaccination status.
The main purpose of this study is to describe the birthweight of children born in the rural districts of Guinea-Bissau. We will then compare the birthweight of children born to mothers, who have had the BCG-vaccine, to children born to mothers who have not had the vaccine.  

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Rationale

BCG scarification is a lifelong and easy-assessable marker for a correctly administered BCG vaccine. Within a large randomised trial of the effects of early BCG vaccination on early life mortality in rural Guinea-Bissau, we are conducting home visits, where all children will be weighed during the first 3 days of life. We register maternal BCG scar at the time of consent. We will take advantage of this situation to describe birthweight among the mainly home delivered infants in rural Guinea-Bissau and assess the association between maternal BCG scar status and birthweight. An association between maternal BCG and birthweight could be dependent on which children have their birthweight assessed. Therefore, we will assess whether there is an association between maternal BCG scar and adverse pregnancy outcome/time to delivery.

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Description of the cohort

The study is conducted in three rural areas around the capital of Guinea-Bissau, called Bissau. The three areas are Oio, Biombo and Cacheu. Women are enrolled at the age 14-16 or when they move to one of the ressearch areas.
The women are ten routinely followed through monthly visits. It is at these visits that pregnancies are registered. When a pregnancy is registered, the woman's nutritional and socio-economic statuses are assesed. Information on antenatal care is registered twice, prior to giving birth and after delivery.
During the first 3 days of life the child and the mother are visited. Here the child is weighed and the mothers arm is inspected for the pressence of a BCG-scar. 

Data and biological material

The women are questioned by nurses and local healthworkers via questionaires. The above mentioned information is registered. 

Collaborating researchers and departments

Faculty of Health Sciences, University of Southern Denmark

• Medical student Alexander Dahl Stjernholm
• PhD-student Sanne Thysen, MD

OPEN Odense Patient data Explorative Network, Odense University Hospital & Statens Serum Institut

• Associate professor Ane Bærent Fisker, MD, PhD
• Professor Christine Stabell Benn, MD, DMSc, PhD

Statens Serum Institut

• Peter Aaby, DMSc
• Amabelia Rodrigues, PhD
• Statistician Aksel Jensen, PhD