Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model

Completed

• Conditions: Immunologic Activity Alteration; Preterm Birth

• Registration Number: NCT03796949
• Lead Sponsor: Linkoeping University

Brief Summary

This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.

Detailed Description

Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated.

In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor.

Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2019-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Study First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 204

Inclusion Criteria

• Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes
• Age > 18 years
• Swedish-speaking (understanding study information)

Exclusion Criteria

• Multiple gestation
• Blood borne infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of delivery	Outcome noted at delivery	Delivery before 34 weeks of gestation or after 34 weeks of gestation