Preterm Premature Rupture of Membranesmelatonin&PROMNCT04588220
Melatonin, Soluble Urokinase-type Plasminogen Activator Receptor, and Orosomucoid 2 Levels in PPROM
An observational study of Preterm Premature Rupture of Membranes, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Premature Rupture of Membranes
- What is being tested?
- Obstetric ultrasound and fetal-maternal assessment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2020to 30 Dec 2021
- 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 40 years
- Women only
- Adult
Study population: The investigators consecutively will be recruited 44 subjects with PPROM, and 44 healthy pregnancies will be selected for the control group.
Who may be able to join
- Pregnant women complicated with PPROM
- Healthy pregnant women who will be delivered at term
- Singleton pregnancy
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cengiz Gokcek Women's and Children's Hospital
Gaziantep
About this study
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
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.
Read the 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: 2020/276). 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 PPROM(n=44) compared to those of volunteer healthy pregnant women (n=44). Then, these three markers levels at maternal serum and cord serum will be evaluated for histological chorioamnionitis and maternal/neonatal outcomes in the study group.
- Conditions
- Preterm Premature Rupture of Membranes
- Being tested
- Obstetric ultrasound and fetal-maternal assessment
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric ultrasound and fetal-maternal assessmentOther
Also called melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurements
melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurements
| Study group | Role | What they receive |
|---|---|---|
| preterm premature rupture of membranes | Preterm premature rupture of membranes is the rupture of membranes during pregnancy before 37 weeks' gestation. Receives: 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. Receives: Other: Obstetric ultrasound and fetal-maternal assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
melatonin levels in PPROM
The primary outcome in these analyses will compare maternal serum melatonin concentrations in PPROM group and control group.
Measured: 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.
Measured: 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.
Measured: 1 week
Secondary outcomes (1)
markers levels for histological chorioamnionitis in PPROM
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Oct 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of MembranesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cengiz Gokcek Women's and Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588220
- Sponsor's protocol ID
- CengizGWCH10
- Acronym
- melatonin&PROM
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 72071Wilkinson 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.
PubMed 27022888Committee 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.
PubMed 29266075Desdicioglu 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.
PubMed 29033107
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04588220
- Acronym / sponsor ID
- melatonin&PROM / CengizGWCH10
- Conditions
- Preterm Premature Rupture of Membranes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 19 Oct 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.
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.
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: 2020/276). 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 PPROM(n=44) compared to those of volunteer healthy pregnant women (n=44). Then, these three markers levels at maternal serum and cord serum will be evaluated for histological chorioamnionitis and maternal/neonatal outcomes in the study group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm premature rupture of membranes | – | Other: Obstetric ultrasound and fetal-maternal assessmentPreterm premature rupture of membranes is the rupture of membranes during pregnancy before 37 weeks' gestation. |
| Control group | – | Other: Obstetric ultrasound and fetal-maternal assessmentHealthy 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The investigators consecutively will be recruited 44 subjects with PPROM, and 44 healthy pregnancies will be selected for the control group.
Key inclusion criteria (3 listed)
- Pregnant women complicated with PPROM
- Healthy pregnant women who will be delivered at term
- Singleton pregnancy
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Obstetric ultrasound and fetal-maternal assessmentAlso: melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurementsmelatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurements | Other | Control group, preterm premature rupture of membranes |
Primary outcome
melatonin levels in PPROM
Time frame: 1 week
The primary outcome in these analyses will compare maternal serum melatonin concentrations in PPROM group and control group.
soluble urokinase-type plasminogen activator receptor levels in PPROM
Time frame: 1 week
The other primary outcome in these analyses will compare maternal serum soluble urokinase-type plasminogen activator receptor concentrations in PPROM group and control group.
orosomucoid 2 levels in PPROM
Time frame: 1 week
The primary outcome in these analyses will compare maternal serum orosomucoid 2 concentrations in PPROM group and control group.
1 secondary outcome
markers levels for histological chorioamnionitis in PPROM
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 72071Ekstrom 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.
- Background: PubMed 27022888Wilkinson 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.
- Background: PubMed 29266075Committee 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.
- Results publication: PubMed 29033107Desdicioglu 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Premature Rupture of Membranes, run by Cengiz Gokcek Women's and Children's Hospital 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
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?
melatonin levels in PPROM (time frame: 1 week). The study lists 3 primary outcomes in all. 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 NCT04588220, which also lists 4 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 19 Oct 2020.