Trace Elements and Heavy Metals at PPROM

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.

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Key information

Conditions

Preterm Rupture of Membranes Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

The primary endpoint

Time frame: 3 months

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.

Sponsors and collaborators

Lead sponsor

Cengiz Gokcek Women's and Children's Hospital

Other

Registry information

Official study title

Maternal Serum Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Preterm Prelabor Rupture of Membranes

Acronym: metals&PROM

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Sep 4, 2019
Registry last updated: Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed