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
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.
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:
Excusion criteria:
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.
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 →This is the only study on the registry with Ismail Biyik as lead sponsor.
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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.
Exclusion Criteria:
Pregnant women who give birth before 37th gestational week
Diagnostic Test: Serum sample analysis
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
Gestational age at birth
Preterm: \<37 gestational week Term: ≥37 gestational week
Time frame: December 2019 - January 2021
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
Mode of delivery
Vaginal delivery Cesarean delivery
Time frame: December 2019 - January 2021
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
Plan to share: No
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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