O60 O34.3
Conditions
Interventions
Group 1: Collection of a cervicovaginal fluid (CVF) swab in case of threatened preterm birth. Placement of the swab in 500µl buffer solution with extraction of the CVF. Quantitative measurement of of
Sponsors
Universitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women with singleton pregnancy between 22+0 and 31+6 weeks of gestation. Age > 18 years with signs or symptoms of threatened preterm birth: regular (>3/30min) and/or painful uterine contractions, shortening of the cervix <25mm
Exclusion criteria
Exclusion criteria: Opening of the cervix >3cm, cerclage suture in situ, intravaginal placement of a pessary, maternal temperature >37.5°C, preterm rupture of membranes, vaginal bleeding, vaginal examination or transvaginal ultrasound during the last 6 hours, sexual intercourse during the last 24 hours, vaginal pH =5.0, multiple pregnancy, tocolysis during the last 7 days, hypertensive pregnancy disorder, necessity of iatrogenic indicated delivery in the next 7 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Test characteristics of the investigated biomarkers in respect to the frequency of preterm birth < 32+0 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Test characteristics of the investigated biomarkers in respect to the frequency of preterm birth < 37+0 weeks of gestation and time interval between diagnosis and delivery, occurrence of severe neonatal morbidity (necrotizing enterocolitis, intraventricular hemorrhage, grade III and IV, bronchopulmonary dysplasia, sepsis) and mortalitiy. | — |
Countries
Germany
Contacts
Public ContactJohannes Stubert
Universitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock
Outcome results
None listed