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Melatonin, Soluble Urokinase-type Plasminogen Activator Receptor, and Orosomucoid 2 Levels in PPROM

NCT04588220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2020-10-19

No results posted yet for this study

Summary

Introduction: To evaluate the maternal blood serum melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 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 melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 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.

Conditions

  • Preterm Premature Rupture of Membranes

Interventions

OTHER

Obstetric ultrasound and fetal-maternal assessment

melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurements

Sponsors & Collaborators

  • Cengiz Gokcek Women's and Children's Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2021-10-30
Completion
2021-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588220 on ClinicalTrials.gov