Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588220
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-10-08
Brief Title:
Melatonin Soluble Urokinase-type Plasminogen Activator Receptor and Orosomucoid 2 Levels in PPROM
Sponsor:
Cengiz Gokcek Womens and Childrens Hospital
Organization:
Cengiz Gokcek Womens and Childrens Hospital
Study Overview
Official Title:
Umbilical Cord and Maternal Blood Concentrations of Melatonin Soluble Urokinase-type Plasminogen Activator Receptor and Orosomucoid 2 in Pregnancy Complicated by Preterm Premature Rupture of the Membranes and Histological Chorioamnionitis
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
melatoninPROM
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 maternalumbilical 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 maternalneonatal outcomes
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 maternalneonatal outcomes
Detailed Description:
This observational case-control study will be conducted at the Department of Obstetrics and Gynecology Cengiz Gokcek Public Hospital Gaziantep Turkey between October 2020 and October 2021 The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University reference no 2020276 The study strictly will be adhered to the principles of the Declaration of Helsinki All subjects will be included in the study gave oral and written informed consent Membrane rupture before labor and before 37 weeks of gestation is referred to as preterm premature rupture of membranes PPROM Every woman in the study population will be undergone obstetric ultrasound examination and fetal-maternal assessment will be carried out The blood for analysis will be firstly obtained in maternal blood on the day of diagnosis at the study 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 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 All The participants with PPROM will be also hospitalized Then the protocols for pregnant women with PPROM in our hospital are as follows All patients with PPROM are hospitalized and expectant protocol is applied After hospitalization until the delivery of baby all pregnant women with PPROM receive prophylactic antibiotics for 1 week and betamethasone injection The non-stress test and fetal movement determined by the mother are used for the detection of fetal well-being The signs for clinical chorioamnionitis such as uterine tenderness fever purulent discharges from the cervical canal and inflammatory markers like white blood cell count WBC and C-reactive protein CRP levels are monitored carefully during the hospitalization After a latency period PPROM pregnancy will gone to spontaneous delivery or will be applied termination procedure In the study group the placenta will be stained with hematoxylin-eosin and will be examined under a light microscope for histological signs of neutrophil infiltration and chorioamnionitis Then this study will be determined maternal serum melatonin soluble urokinase-type plasminogen activator receptor and orosomucoid 2 levels in women with PPROMn44 compared to those of volunteer healthy pregnant women n44 Then these three markers levels at maternal serum and cord serum will be evaluated for histological chorioamnionitis and maternalneonatal outcomes in the study group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None