Analysis of diagnostic accuracy of predictive biomarkers in risk assessment of threatening preterm birth

• Conditions: O60; O34.3; Preterm labour and delivery; Maternal care for cervical incompetence

• Registration Number: DRKS00010763
• Lead Sponsor: niversitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-02
• Study Completion: 2019-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 110

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test characteristics of the investigated biomarkers in respect to the frequency of preterm birth < 32+0 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
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.