Trace Elements and Heavy Metals at PPROM

Completed

• Conditions: Preterm Rupture of Membranes
• Interventions: Diagnostic Test: maternal serum concentration of trace elements and heavy metals levels

• Registration Number: NCT04077944
• Lead Sponsor: Cengiz Gokcek Women's and Children's Hospital

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.

Study Timeline

• Study Start: 2018-08-29
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-30
• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-08-31
• Status Verified: 2019-09
• Study First Posted: 2019-09-04
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm prelabor rupture of membranes	maternal serum concentration of trace elements and heavy metals levels	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	maternal serum concentration of trace elements and heavy metals levels	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.

Primary Outcome Measures

Name	Time	Method
The primary endpoint	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.

Trial Locations

Locations (1)

Cengiz Gokcek Women's and Child's hospital; 🇹🇷 Gaziantep, Turkey