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CompletedNCT04451928Updated Mar 3, 2021

Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour

An observational study in Preterm Birth, sponsored by Ismail Biyik. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Ismail Biyik · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
51
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the detailed description

The study will include 90 singleton pregnant women between the ages of 18 and 42 and gestational ages of 24 and 37 weeks.

Inclusion criteria:

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

Excusion criteria:

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

Patients who are hospitalized due to preterm labor will primarily receive bed rest and hydration. If cervical changes persist or if contractions continue after 2 hours after intravenous hydration, tocolytic treatment will be started. Calcium channel blockers will be used as tocolytic drug. Maternal corticosteroid (12 mg intramuscular betamethasone within 24 hours) will be given to accelerate fetal lung development. After 48 hours after steroid administration, tocolysis will be stopped. Demographic datas of the patients will be recorded. Patients will be followed until delivery. The gestational week will be determined according to the last menstrual date and will be confirmed by early ultrasonographic measurements. The gestational week at birth and the time between admission to the hospital and birth will be recorded. Delivery time will be divided into groups within 24 hours, 48 hours, 7 days, 14 days, and ≤37 weeks after admission. Mode of delivery, baby's birth weight, APGAR score will be recorded.

Venous blood samples will be taken from patients before medication. Serum samples will be stored in the cooler set to -80 °C until analysis. Levels of ischemia-modified albumin, biglycan and decorin levels will be examined by enzyme-linked immunosorbent assay (ELISA) method.

Statistical analysis:

After the assessment of the data, the variables between two groups will be compared by Mann Whitney U test, Student T test, Fisher Exact Test, Chi-Square Analysis. Regression model will be conducted in order to estimate the probability of the preterm birth. A value of p \< 0.05 will be considered statistically significant.

02

Conditions studied

  • Preterm Birth

Keywords

  • preterm birth
  • ischemia modified albumin
  • biglycan
  • decorin
  • prediction
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 51 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

This is the only study on the registry with Ismail Biyik as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
51 participants (actual)
Target follow-up
13 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testSerum sample analysis

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

06

What researchers measure

Primary outcomes

  1. Gestational age at birth

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

    Time frame: December 2019 - January 2021

Secondary outcomes

  1. Hospital admission and delivery interval

    Delivery time will be divided into groups within; 48 hours, 7 days, 14 days, * 35 weeks and * 37 weeks after hospital admission.

    Time frame: December 2019 - January 2021

  2. Mode of delivery

    Vaginal delivery Cesarean delivery

    Time frame: December 2019 - January 2021

  3. APGAR score

    Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." of newborn at 1 and 5 minutes after delivery.

    Time frame: December 2019 - January 2021

07

Study locations

1 site
  • Kütahya Medical Sciences University
    Kütahya, 43000, Turkey
08

References and documents

Publications

  • 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. PubMed 23891063 ↗
  • 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. PubMed 30895897 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04451928
Lead sponsor
Ismail Biyik
Responsible party
Ismail Biyik (Assistant Professor, Kutahya Health Sciences University) — Sponsor-investigator
First posted
Jun 30, 2020
Start date
Dec 1, 2019
Primary completion
Feb 5, 2021
Completion
Feb 5, 2021
Last update
Mar 3, 2021

Study contacts

Ismail Biyik, MD
principal investigator · Kütahya Medical Sciences University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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