Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour
Condition: Preterm Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature; Ischemia
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): Serum sample analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels
Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      Serum
    
Keywords: preterm birth; ischemia modified albumin; biglycan; decorin; prediction