Threatened Preterm Birth and Time of Subsequent Delivery... | NCT03796949

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

NCT03796949

Sponsor

Linkoeping University

Status

Completed

Last Update Posted

Jan 8, 2019Actual

Enrollment

204Actual

Phase

Not provided

Conditions

Preterm Birth
Immunologic Activity Alteration

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jan 7, 2019

First Submission Date that Met QC Criteria

Jan 7, 2019

First Posted Date

Jan 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2019

Last Update Posted Date

Jan 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie Blomberg, MD PhD	Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

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