Short summary

This is a pilot and feasibility study with three aims: 

1: To assess the compliance of the pregnant women participating in the study 

2: To analyse the microbiome during the pregnancy 

3: To observe the obstetric outcomes.

Rationale

Worldwide 10% of babies are born preterm (before 37 weeks of gestation). Preterm birth is the single largest direct cause of neonatal morbidity and mortality. Approximately 30 % of preterm births can be attributed to intrauterine infection or inflammation. 

Thus the microbiome of the pregnant woman is important in maintaining a healthy pregnancy, and it therefore plays and important role in preventing preterm birth. By changing the microbiome it is theoretically possible to increase gestational length. 

We therefore designed a pilot and feasibility study where pregnant women are randomised into two groups; an intervention group eating a healthy nutrition product containing, amongst other things, probiotics and a control group not eating the nutrition product. Women i both groups are collecting microbiome samples from vagina and rectum.

The aim of the study is to assess the compliance of the women in each group and to analyse the microbiome three times during pregnancy (at 12, 22 and 30 gestational weeks). Finally obstetric outcomes will be observed.

Description of the cohort

Pregnant women with higth risk of preterm birth:

1. Women with a previous spontanious preterm birth (<37 GW)

2. Women with a previous spontanious abortion (> 16 GW)

3. Women with conic section

Data and biological material

Samples from vagina and rectum are collected to analyse the microbiome of the pregnant women. Questionaires are used to assess the compliance of the pregnant women, and a obstetric database is used to register obstetric outcomes.

Collaborating researchers and departments

Department of Obstetrics and Gynaecology, Odense University Hospital

• Professor Ellen Nøhr, PhD
• Christina Vinter, PhD
• Julie Ribe Bagge, MSc (Midwifery)

Institute of Clinical Research, University of Southern Denmark

• Professor Ronnie Lamont, BSc MB ChB MD FRCOG