NCT03796949

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

4.3 years

First QC Date

January 7, 2019

Last Update Submit

January 7, 2019

Conditions

Preterm BirthImmunologic Activity Alteration

Outcome Measures

Primary Outcomes (1)

  • Time of delivery

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

    Outcome noted at delivery

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • Multiple gestation
  • Blood borne infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples Serum samples RNA samples Placental biopsies

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Marie Blomberg, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 8, 2019

Study Start

May 1, 2014

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share