Preterm BirthNCT04451928
Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour
An observational study of Preterm Birth, run by Ismail Biyik at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Serum sample analysis
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 5 Feb 2021
- How long will I take part?
- 13 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Multiple pregnancy
- Preterm premature rupture of membranes
- Abnormal placentation (such as placenta previa)
- Uterine anomaly
- Maternal heart disease
- Inflammatory or infectious disease
Show all 12Show fewer
- Preeclampsia
- Fetal growth restriction
- Congenital fetal anomaly
- Polyhydramnios
- Acute chorioamnionitis
- Medically induced preterm delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Medical Sciences University
Kütahya, 43000
About this study
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Serum sample analysis
- Keywords
- preterm birth, ischemia modified albumin, biglycan, decorin, prediction
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum sample analysisDiagnostic test
Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels
| Study group | Role | What they receive |
|---|---|---|
| Preterm delivery | Pregnant women who give birth before 37th gestational week Receives: Diagnostic Test: Serum sample analysis | |
| Term delivery | Pregnant women who will give birth 37th and after gestational week Receives: Diagnostic Test: Serum sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
Preterm: <37 gestational week Term: ≥37 gestational week
Measured: December 2019 - January 2021
Secondary outcomes (3)
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.
Measured: December 2019 - January 2021
Mode of delivery
Vaginal delivery Cesarean delivery
Measured: December 2019 - January 2021
APGAR score
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." of newborn at 1 and 5 minutes after delivery.
Measured: December 2019 - January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Dec 2019
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 13 Months
Sponsor and investigators
- Lead sponsor
- Ismail Biyik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ismail Biyik, Kutahya Health Sciences University
- Investigators
- Ismail Biyik, MD, Principal investigator, Kütahya Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451928
- Sponsor's protocol ID
- 2020/01-1
- Status last verified
- Mar 2021
- First submitted
- 25 Jun 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23891063Underhill 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.
PubMed 30895897Biyik 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.
PubMed 38141595
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour
- ClinicalTrials.gov ID
- NCT04451928
- Acronym / sponsor ID
- 2020/01-1
- Conditions
- Preterm Birth
- Keywords
- preterm birth, ischemia modified albumin, biglycan, decorin, prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ismail BiyikUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 13 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm delivery | – | Diagnostic Test: Serum sample analysisPregnant women who give birth before 37th gestational week |
| Term delivery | – | Diagnostic Test: Serum sample analysisPregnant women who will give birth 37th and after gestational week |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Multiple pregnancy
- Preterm premature rupture of membranes
- Abnormal placentation (such as placenta previa)
- Uterine anomaly
- Maternal heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum sample analysisAnalysis of the levels of ischemia-modified albumin, biglycan and decorin levels | Diagnostic test | Preterm delivery, Term delivery |
Primary outcome
Gestational age at birth
Time frame: December 2019 - January 2021
Preterm: <37 gestational week Term: ≥37 gestational week
3 secondary outcomes
Hospital admission and delivery interval
Time frame: December 2019 - January 2021
Mode of delivery
Time frame: December 2019 - January 2021
APGAR score
Time frame: December 2019 - January 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 23891063Rossi 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.
- Background: PubMed 30895897Underhill 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.
- Derived from this study: PubMed 38141595Biyik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Biyik, MD principal investigator
Kütahya Medical Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Ismail Biyik at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at birth (time frame: December 2019 - January 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451928, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.