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

Sponsor

Ismail Biyik (Other)

Overall Status

Completed

CT.gov ID

NCT04451928

Collaborator

(none)

Enrollment

Location

14.2

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

Feb 5, 2021

Actual Study Completion Date :

Feb 5, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Gestational age at birth [December 2019 - January 2021]
Preterm: <37 gestational week Term: ≥37 gestational week

Secondary Outcome Measures

Hospital admission and delivery interval [December 2019 - January 2021]
Delivery time will be divided into groups within; 48 hours, 7 days, 14 days, 35 weeks and 37 weeks after hospital admission.
Mode of delivery [December 2019 - January 2021]
Vaginal delivery Cesarean delivery
APGAR score [December 2019 - January 2021]
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." of newborn at 1 and 5 minutes after delivery.