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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451928
• Other study ID #: 2020/01-1
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: February 5, 2021

Study information

• Verified date: March 2021
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

Diagnostic Test:
• Serum sample analysis
Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels

Locations

Country	Name	City	State
Turkey	Kütahya Medical Sciences University	Kütahya

Sponsors (1)

Lead Sponsor	Collaborator
Ismail Biyik

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at birth	Preterm: <37 gestational week Term: =37 gestational week	December 2019 - January 2021
Secondary	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.	December 2019 - January 2021
Secondary	Mode of delivery	Vaginal delivery Cesarean delivery	December 2019 - January 2021
Secondary	APGAR score	Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." of newborn at 1 and 5 minutes after delivery.	December 2019 - January 2021