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Objectives: To evaluate maternal serum trace elements and heavy metals namely, aluminum (Al), chromium (Cr), manganese (Mn), cobalt (Co), nickel (Ni), copper (Cu), zinc (Zn), arsenic (As), molybdenum (Mo), cadmium (Cd), tin (Sn), antimony (Sb), mercury (Hg), and lead (Pb) in pregnant women complicated by preterm prelabour rupture of the membranes (pP-ROM) and to compare the results with healthy pregnancies.
Methods: Maternal serum levels of Al, Cr, Mn, Co, Ni, Cu, Zn, As, Mo, Cd, Sn, Sb, Hg, and Pb were measured in the study group, which included 55 pregnant women complicated with pP-ROM and 60 healthy pregnancies (control group) with respect to maternal age and gestational weeks. The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS) and compared.
This current observational study was conducted at Cengiz Gokcek Women's and Children's Hospital Gaziantep, Turkey at the Department of Obstetrics and Gynecology between dates of August 2018 and March 2019. The experiment was conducted according to the Declaration of Helsinki. All subjects included in the study gave oral and written informed consents. The study population consisted of 55 women with a singleton pregnancy who were diagnosed with pP-ROM between 24+0 and 36+6 weeks of gestation. The control cases were recruited from the healthy pregnant women with a gestational age-matched cohort who admitted for routine obstetric care to our outpatient clinic. Sixty healthy pregnant women who delivered at term were included in the study as the control group. All patients will gave their oral and written informed consent before their inclusion in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm prelabor rupture of membranes | The diagnosis of Preterm prelabor rupture of membranes was made in the case of apparent spontaneous leakage of AF from the cervical canal during sterile speculum inspection before the onset of active labor at 37 weeks of pregnancy. The study population consisted of 55 women with a singleton pregnancy who were diagnosed with pP-ROM between 24+0 and 36+6 weeks of gestation. The Amnisure test (AmniSure International LLC, Boston, MA) was used when there was inconclusive results to confirm the final diagnosis. The gestational age was determined by calculation from the last menstrual period and supported by the ultrasonography measurements at the first trimester of gestation. |
| |
| Control | The control cases were recruited from the healthy pregnant women with a gestational age-matched cohort who admitted for routine obstetric care to our outpatient clinic. Sixty healthy pregnant women who delivered at term were included in the study as the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maternal serum concentration of trace elements and heavy metals levels | Diagnostic Test | The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS) |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint | The primary endpoint in this analysis is to evaluate maternal serum trace elements and heavy metals namely, aluminum (Al), chromium (Cr), manganese (Mn), cobalt (Co), nickel (Ni), copper (Cu), zinc (Zn), arsenic (As), molybdenum (Mo), cadmium (Cd), tin (Sn), antimony (Sb), mercury (Hg), and lead (Pb) in pregnant women complicated by preterm prelabor rupture of the membranes (pP-ROM) and to compare the results with healthy pregnancies. The elements, Al, Cr, Mn, Co, Ni, Cu, Zn, As, Mo, Cd, Sn, Sb, Hg and Pb were measured using an inductively coupled plasma-mass spectrometry (ICP-MS) (Thermo Scientific ICAPQc, USA). In the present study, only the maternal serum levels of fourteen different TEs and HMs were evaluated in order to examine the association between the occurrence of pP-ROM and these elements. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
• pregnant women who had the diagnosis of chorioamnionitis at the time of first admission
preterm prelabour rupture of the membranes is described as rupture of the amniotic membranes prior to 37 weeks of completed gestation.
The investigators consecutively will recruite 55 subjects with preterm prelabor rupture of the membranes, and 60 healthy preganancies will selected for the control group.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cengiz Gokcek Women's and Child's hospital | Gaziantep | 27010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28446135 | Background | Igbinosa I, Moore FA 3rd, Johnson C, Block JE. Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy Childbirth. 2017 Apr 26;17(1):128. doi: 10.1186/s12884-017-1311-y. | |
| 28476444 | Background | Wang KC, Lee WL, Wang PH. Early and late preterm premature rupture of membranes. J Chin Med Assoc. 2017 Oct;80(10):613-614. doi: 10.1016/j.jcma.2017.03.006. Epub 2017 May 2. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2018 | Aug 31, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 20576532 | Result | Vigeh M, Yokoyama K, Shinohara A, Afshinrokh M, Yunesian M. Early pregnancy blood lead levels and the risk of premature rupture of the membranes. Reprod Toxicol. 2010 Nov;30(3):477-80. doi: 10.1016/j.reprotox.2010.05.007. Epub 2010 May 16. |