NCT04451928

Brief Summary

In this study, the levels of ischemia modified albumin, biglycan and decorin in the serums of pregnant women hospitalized for preterm labor will be examined. Their serum levels will be compared between women having preterm and term delivery. Their accuracy will be asessed in predicting preterm birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

June 25, 2020

Last Update Submit

March 1, 2021

Conditions

Preterm Birth

Keywords

preterm birthischemia modified albuminbiglycandecorinprediction

Outcome Measures

Primary Outcomes (1)

  • Gestational age at birth

    Preterm: \<37 gestational week Term: ≥37 gestational week

    December 2019 - January 2021

Secondary Outcomes (3)

  • Hospital admission and delivery interval

    December 2019 - January 2021

  • Mode of delivery

    December 2019 - January 2021

  • APGAR score

    December 2019 - January 2021

Study Arms (2)

Preterm delivery

Pregnant women who give birth before 37th gestational week

Diagnostic Test: Serum sample analysis

Term delivery

Pregnant women who will give birth 37th and after gestational week

Diagnostic Test: Serum sample analysis

Interventions

Serum sample analysisDIAGNOSTIC_TEST

Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels

Preterm deliveryTerm delivery

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSingleton pregnant women between the ages of 18 and 42 and gestational ages of 24 and 37 weeks.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who are hospitalized due to preterm labor. Preterm labor is defined as regular contractions (uterine contraction ≥3 times at 30 minutes) of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy.

You may qualify if:

  • Singleton pregnancy
  • Gestational age is between 24-37 weeks
  • Cervical dilatation less than 3 cm and cervical effacement less than 80%
  • Uterine contraction ≥3 times at 30 minutes
  • Intact amniotic membrane

You may not qualify if:

  • Multiple pregnancy
  • Preterm premature rupture of membranes
  • Abnormal placentation (such as placenta previa)
  • Uterine anomaly
  • Maternal heart disease
  • Inflammatory or infectious disease
  • Preeclampsia
  • Fetal growth restriction
  • Congenital fetal anomaly
  • Polyhydramnios
  • Acute chorioamnionitis
  • Medically induced preterm delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Medical Sciences University

Kütahya, 43000, Turkey (Türkiye)

Location

Related Publications (3)

  • Rossi A, Bortolotti N, Vescovo S, Romanello I, Forzano L, Londero AP, Ambrosini G, Marchesoni D, Curcio F. Ischemia-modified albumin in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):348-51. doi: 10.1016/j.ejogrb.2013.06.037. Epub 2013 Jul 23.

    PMID: 23891063BACKGROUND

  • Underhill LA, Avalos N, Tucker R, Zhang Z, Messerlian G, Lechner B. Serum Decorin and Biglycan as Potential Biomarkers to Predict PPROM in Early Gestation. Reprod Sci. 2019 Mar 21:1933719119831790. doi: 10.1177/1933719119831790. Online ahead of print.

    PMID: 30895897BACKGROUND

  • Biyik I, Soysal C, Ince OUO, Durmus S, Oztas E, Keskin N, Isiklar OO, Karaagac OH, Gelisgen R, Uzun H. Prediction of Preterm Delivery Using Serum Ischemia Modified Albumin, Biglycan, and Decorin Levels in Women with Threatened Preterm Labor. Rev Bras Ginecol Obstet. 2023 Dec;45(12):e754-e763. doi: 10.1055/s-0043-1772593. Epub 2023 Dec 23.

    PMID: 38141595DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ismail Biyik, MD

    Kütahya Medical Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
13 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

December 1, 2019

Primary Completion

February 5, 2021

Study Completion

February 5, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)