Trace Elements and Heavy Metals at PPROM

NCT04077944 | Completed

• 1 other identifier: CengizGWCH4
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Diagnostic Test: maternal serum concentration of trace elements and heavy metals levels

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.

Diagnostic Test: maternal serum concentration of trace elements and heavy metals levels

Interventions

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)

Control; Preterm prelabor rupture of membranes

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: preterm prelabour rupture of the membranes is described as rupture of the amniotic membranes prior to 37 weeks of completed gestation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively will recruite 55 subjects with preterm prelabor rupture of the membranes, and 60 healthy preganancies will selected for the control group.

You may qualify if:

• preterm prelabor rupture of the membranes
• healthy pregnancy

You may not qualify if:

• pregnant women who had the diagnosis of chorioamnionitis at the time of first admission
• women with chronic medical diseases
• gestational diabetes mellitus
• women with a history of drug use throughout pregnancy
• drug users
• pregnant women who have received any treatment for pP-ROM at the time of admission
• patients who had fetal congenital abnormalities or genetic syndromes
• genetic syndromes
• multiple gestation
• active labor
• fetal hypoxia
• fetal growth restriction

Sponsors & Collaborators

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

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28446135 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.

  PMID: 28476444 BACKGROUND

• 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.

  PMID: 20576532 RESULT

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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: August 31, 2019
• First Posted: September 4, 2019
• Study Start: August 29, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 30, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

TU (1)