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OpenTrials
Completed

NCT Number: NCT03796949

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

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

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Immunologic Activity Alteration Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time of delivery

    Time frame: Outcome noted at delivery

    Delivery before 34 weeks of gestation or after 34 weeks of gestation

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2019
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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