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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Diagnostic test: Serum sample analysis

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey, 43000
    • Kütahya Medical Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm delivery; Pregnant women who give birth before 37th gestational week	Diagnostic test: Serum sample analysis; Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels
Term delivery; Pregnant women who will give birth 37th and after gestational week	Diagnostic test: Serum sample analysis; Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at birth	Preterm: <37 gestational week Term: ≥37 gestational week	December 2019 - January 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	December 2019 - January 2021
Mode of delivery	Vaginal delivery Cesarean delivery	December 2019 - January 2021
APGAR score	Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." of newborn at 1 and 5 minutes after delivery.	December 2019 - January 2021

Collaborators and Investigators

• Sponsor: Ismail Biyik
• Investigators: Principal Investigator: Ismail Biyik, MD, Kütahya Medical Sciences University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: preterm birth; prediction; ischemia modified albumin; biglycan; decorin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Ischemia; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 2020/01-1

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