- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532021
Matrix Metalloproteinase 14, Neopterin, and Orosomucoid 1 Levels in PPROM (MMP-14&PPROM)
Umbilical Cord and Maternal Blood Concentrations of Matrix Metalloproteinase 14, Neopterin, and Orosomucoid 1 in Pregnancy Complicated by Preterm Premature Rupture of the Membranes and Histological Chorioamnionitis
Introduction: To evaluate the maternal blood serum matrix metalloproteinase 14, neopterin, and orosomucoid 1 levels in pregnant women complicated by preterm premature rupture of membranes (PPROM) and to compare the results with healthy pregnancies. In addition, to determine whether maternal/umbilical cord blood concentrations of matrix metalloproteinase 14, neopterin, and orosomucoid 1 are of value in the diagnosis of histological chorioamnionitis in patients with preterm premature rupture of membranes (PPROM).
Methods: This cohort study will be included 44 pregnant women with PPROM and 44 gestational age-matched healthy subjects in 24-32 weeks of pregnancy. The blood for analysis will be firstly obtained in maternal blood on the day of diagnosis at the study group. Healthy subjects who have a normal pregnancy and outcomes without any fetal-neonatal complications will be accepted into the control group. Forty-four gestational age-matched healthy pregnant women who will be delivered at term will be included in the study as the control group. In the control group, the pregnant women will be taken the maternal blood at the admission day. The women in both groups will be observed until the delivery and perinatal data will be noted. Then, the blood for analysis will be secondly obtained in maternal blood during termination of the pregnancy (or spontaneous labor) at the study group. Lastly, the blood for analysis will be also obtained in umbilical cord blood at the study group. These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. The placenta will be sent to histological examination in the study group. These three markers levels in women with PPROM will be compared to those of volunteer healthy pregnant women. In the study group, these three markers levels at maternal serum and cord serum will be evaluated for histological chorioamnionitis and maternal/neonatal outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Gaziantep, Turkey
- Cengiz Gokcek Women's and Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women complicated with PPROM
- Healthy pregnant women who will be delivered at term
- Singleton pregnancy
Exclusion Criteria:
- pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
- women who have dyed their hair in the last 9 months
- history of using any medication
- presence of gestational hypertension or gestational diabetes
- drug user
- patients who had fetal congenital abnormalities or genetic syndromes
- multiple-gestation pregnancies
- intrauterine fetal death
- women who had any other infection or fever
- fetal distress at admission
- cord prolapse
- active labor
- antenatal bleeding
- cervical or uterine anomaly
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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preterm premature rupture of membranes
Preterm premature rupture of membranes is the rupture of membranes during pregnancy before 37 weeks' gestation.
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These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
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control group
Healthy subjects who had a normal pregnancy and outcomes without any fetal-neonatal complications will be accepted into the control group.
Forty-four gestational age-matched healthy pregnant women who will be delivered at term will be included in the study as the control group.
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These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MMP-14 levels in PPROM
Time Frame: 1 week
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The primary outcome in these analyses will compare maternal serum matrix metalloproteinase 14, neopterin, and orosomucoid 1 concentrations in PPROM group and control group.
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1 week
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neopterin levels in PPROM
Time Frame: 1 week
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The other primary outcome in these analyses will compare maternal serum neopterin concentrations in PPROM group and control group.
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1 week
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orosomucoid 1 levels in PPROM
Time Frame: 1 week
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The primary outcome in these analyses will compare maternal serum orosomucoid 1 concentrations in PPROM group and control group.
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
markers levels for histological chorioamnionitis in PPROM
Time Frame: 1 week
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The secondary result in these analyzes will compare whether there is a difference at the levels of these three markers in maternal serum and cord serum for the presence of histological chorioamnionitis in the study group.
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1 week
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Collaborators and Investigators
Publications and helpful links
General Publications
- Ekstrom B, Berggard I. Human alpha1-microglobulin. Purification procedure, chemical and physiochemical properties. J Biol Chem. 1977 Nov 25;252(22):8048-57. No abstract available.
- Nergiz Avcioglu S, Demircan Sezer S, Kucuk M, Zafer E, Yuksel H, Akcan B, Turgut O. Maternal serum concentrations of s-Endoglin and IL-6 in pregnancy complicated by preterm premature membrane rupture. J Matern Fetal Neonatal Med. 2016;29(12):1957-62. doi: 10.3109/14767058.2015.1070137. Epub 2015 Aug 13.
- Hawinkels LJ, Kuiper P, Wiercinska E, Verspaget HW, Liu Z, Pardali E, Sier CF, ten Dijke P. Matrix metalloproteinase-14 (MT1-MMP)-mediated endoglin shedding inhibits tumor angiogenesis. Cancer Res. 2010 May 15;70(10):4141-50. doi: 10.1158/0008-5472.CAN-09-4466. Epub 2010 Apr 27.
- Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 188: Prelabor Rupture of Membranes. Obstet Gynecol. 2018 Jan;131(1):e1-e14. doi: 10.1097/AOG.0000000000002455.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CengizGWCH9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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