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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm delivery | Pregnant women who give birth before 37th gestational week |
| |
| Term delivery | Pregnant women who will give birth 37th and after gestational week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum sample analysis | Diagnostic Test | Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at birth | Preterm: <37 gestational week Term: ≥37 gestational week | December 2019 - January 2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admission and delivery interval | Delivery time will be divided into groups within; 48 hours, 7 days, 14 days,
| December 2019 - January 2021 |
| Mode of delivery |
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Inclusion Criteria:
Exclusion Criteria:
Singleton pregnant women between the ages of 18 and 42 and gestational ages of 24 and 37 weeks.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ismail Biyik, MD | Kütahya Medical Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kütahya Medical Sciences University | Kütahya | 43000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23891063 | Background | 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. | |
| 30895897 | Background | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Serum
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 |
| 38141595 | Derived | Biyik I, Soysal C, Ince OUO, Durmus S, Oztas E, Keskin N, Isiklar OO, Karaagac OH, Gelisgen R, Uzun H. Prediction of Preterm Delivery Using Serum Ischemia Modified Albumin, Biglycan, and Decorin Levels in Women with Threatened Preterm Labor. Rev Bras Ginecol Obstet. 2023 Dec;45(12):e754-e763. doi: 10.1055/s-0043-1772593. Epub 2023 Dec 23. |
| D000091642 | Urogenital Diseases |