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

NCT ID: NCT03796949

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Preterm Birth Immunologic Activity Alteration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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threatened preterm birth

Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study.

No interventions assigned to this group

Controls

Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marie Blomberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Blomberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden

Other Identifiers

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960624abc

Identifier Type: -

Identifier Source: org_study_id

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