Trace Elements and Heavy Metals at PPROM

NCT ID: NCT04077944

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-03-30

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.

Detailed Description

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.

Conditions

Preterm Rupture of Membranes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

maternal serum concentration of trace elements and heavy metals levels

Intervention Type: 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

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.

maternal serum concentration of trace elements and heavy metals levels

Intervention Type: 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)

Interventions

maternal serum concentration of trace elements and heavy metals levels

The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• preterm prelabor rupture of the membranes
• healthy pregnancy

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cengiz Gokcek Women's and Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Ovayolu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cengiz Gokcek Women's and Child's hospital

Gaziantep, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28446135 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28476444 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20576532 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CengizGWCH4

Identifier Type: -

Identifier Source: org_study_id