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

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

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

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Immunologic Activity Alteration

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 Type: Observational
• Enrollment (Actual): 204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

80 women with threatened preterm labor before 34 weeks of gestation, 40 women with preterm prelabor rupture of the membranes before 34 weeks of gestation, 40 women with normal pregnancies in labor at term, 44 women with normal pregnancies during pregnancy (before labor)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of delivery	Delivery before 34 weeks of gestation or after 34 weeks of gestation	Outcome noted at delivery

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Marie Blomberg, MD PhD, Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 960624abc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No