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NCT03796949 Clinical Trial

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

Preterm Birth Clinical Trial

Official title:
Threatened Preterm Birth and Time of Subsequent Delivery; Prediction Model Based on Biomarkers and Maternal/Obstetrical Characteristics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03796949
Other study ID # 960624abc
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date September 2018

Study information
Verified date January 2019
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date September 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Linkoeping University

Outcome
Type Measure Description Time frame Safety issue
Primary Time of delivery Delivery before 34 weeks of gestation or after 34 weeks of gestation Outcome noted at delivery
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