Clinical trial NCT04451928: Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour
Official title: Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: preterm birth
ischemia modified albumin
biglycan
decorin
prediction
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gestational age at birth
timeFrame: December 2019 - January 2021
Secondary outcomes:
measure: Hospital admission and delivery interval
timeFrame: December 2019 - January 2021
measure: Mode of delivery
timeFrame: December 2019 - January 2021
measure: APGAR score
timeFrame: December 2019 - January 2021
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Medical Sciences University
Study officials:
affiliation: Kütahya Medical Sciences University
name: Ismail Biyik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.