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

NCT04588220 | Unknown

• 1 other identifier: CengizGWCH10
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• melatonin levels in PPROM

  The primary outcome in these analyses will compare maternal serum melatonin concentrations in PPROM group and control group.

  1 week

• soluble urokinase-type plasminogen activator receptor levels in PPROM

  The other primary outcome in these analyses will compare maternal serum soluble urokinase-type plasminogen activator receptor concentrations in PPROM group and control group.

  1 week

• orosomucoid 2 levels in PPROM

  The primary outcome in these analyses will compare maternal serum orosomucoid 2 concentrations in PPROM group and control group.

  1 week

Secondary Outcomes (1)

• markers levels for histological chorioamnionitis in PPROM

  1 week

Study Arms (2)

preterm premature rupture of membranes

Preterm premature rupture of membranes is the rupture of membranes during pregnancy before 37 weeks' gestation.

Other: Obstetric ultrasound and fetal-maternal assessment

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.

Other: Obstetric ultrasound and fetal-maternal assessment

Interventions

Obstetric ultrasound and fetal-maternal assessment OTHER

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

Also known as: melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurements

Control group; preterm premature rupture of membranes

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: PPROM Preterm premature rupture of membranes (PPROM) is defined as the prelabor rupture of membranes before 37 weeks' gestation. Preterm PROM complicates about 1% of deliveries overall.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively will be recruited 44 subjects with PPROM, and 44 healthy pregnancies will be selected for the control group.

You may qualify if:

• Pregnant women complicated with PPROM
• Healthy pregnant women who will be delivered at term
• Singleton pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Children's Hospital

Gaziantep, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 72071 BACKGROUND

• Wilkinson D, Shepherd E, Wallace EM. Melatonin for women in pregnancy for neuroprotection of the fetus. Cochrane Database Syst Rev. 2016 Mar 29;3(3):CD010527. doi: 10.1002/14651858.CD010527.pub2.

  PMID: 27022888 BACKGROUND

• 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.

  PMID: 29266075 BACKGROUND

• Desdicioglu R, Yildirim M, Kocaoglu G, Demir Cendek B, Avcioglu G, Tas EE, Sengul O, Erel O, Yavuz AF. Soluble urokinase-type plasminogen activator receptor (suPAR) and interleukin-6 levels in hyperemesis gravidarum. J Chin Med Assoc. 2018 Sep;81(9):825-829. doi: 10.1016/j.jcma.2017.08.013. Epub 2017 Oct 9.

  PMID: 29033107 RESULT

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: October 7, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

TU (1)