Clinical trial NCT04077944: Trace Elements and Heavy Metals at PPROM
Official title: Maternal Serum Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Preterm Prelabor Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Rupture of Membranes
Lead sponsor: Cengiz Gokcek Women's and Children's Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The primary endpoint
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Cengiz Gokcek Women's and Child's hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.