Consultant Jan Stener Jørgensen Research Unit for Gynaecology and Obstetrics, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
Introducing a special designed, healthy and nourishing nutritional product to reduce the risk of preterm birth - a pilot and feasibility study.
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.
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