NCT05644964

Brief Summary

Anemia by the Centers for Disease Control and Prevention (CDC, 1989); It is defined as hemoglobin (Hb) or hematocrit (Hct) values below the 5th percentile in pregnant women. It is expressed as Hb value of 11 mg / dl or Hct value below 33% in the first trimester. II. Less than 10.5 g / dl in trimester can be defined as anemia. Anemia is a risk factor during pregnancy and one of the predisposing causes of maternal death. Pregnancy anemia can be aggravated by various conditions such as uterine or placental bleeding, gastrointestinal bleeding and peripartum blood loss. In addition to the general consequences of anemia, there are specific risks for the mother and fetus during pregnancy such as intrauterine growth retardation, prematurity, feto-placental miss rate, and higher risk for peripartum blood transfusion. Literature studies on anemia in risky age groups during pregnancy (adolescence and advanced age pregnancy) have been reviewed. Some articles and theses published in Turkey and abroad were found. However, the number of studies related to the study subject in Turkey is quite small. For this reason, conducting a research on the effect of anemia on the placenta during pregnancy will lead to a decrease in the gap in the literature and an increase in the awareness of the public on the subject when the research results are obtained. The research is of a prospective type. The universe of the study will be composed of pregnant women who voluntarily agree to participate in the study chosen by the improbable sampling method. According to the anemia of the pregnant women within the scope of the research; I: Group: Anemic pregnancies under the age of 18 (study group), II: Group: Anemic pregnancies over the age of 35 (study group) III: Group : Pregnant women under the age of 18 are not anemic (control group) IV: Group : Non-anemic pregnant women over the age of 35 (control group) as planned. The placentas of pregnant women who gave birth between 37-42 weeks of age and who voluntarily accepted to participate in the study and who were compatible with age and parity will be examined histopathologically, with a total of at least 30 placentas from each group. Those who had an out-of-term delivery, had multiple pregnancy, preeclampsia, gestational diabetes mellitus, thyroid dysfunction, systemic diseases other than anemia, and those who used drugs other than anemia during pregnancy will not be included in the study. The research will only be conducted with women who have a normal vaginal delivery. In our research, it will be examined whether the possible changes that anemia (anemia) will make in the expression of IRP protein 1 produced from the placenta affect the placenta and the baby. In addition, the relationship between IRP protein 1 and primary related TFrP 1 and indirectly changes in DMT1 expressions will be evaluated, so that the intrauterine growth retardation (IUGG), which is one of the negative effects of anemia in pregnancy, and TFrP 1, are the molecules that increase the end-stage release from the placenta. and its relationship in terms of Dmt1 molecules will be investigated. The tissue samples of placenta that will be obtained after the experiment periods, will be buried in paraffin-embedded blocks after routine tissue tracing, and from the obtained blocks, 5 microns of incisions will be taken via microtome, which will then be stained with Hematoxylin-Eosin and then HPL, IGF and leptin expression levels will be examined with the light microscope by immunohistochemical staining. The results of the research data created by determining the effect of the histopathological examinations on the placentas of women with anemia seen in pregnant women in risky age groups will be a source for the next studies. Maternal anemia (of the mother) seen in pregnancies has been studied many times before, but maternal anemia seen in adolescents and advanced age groups will add a different dimension to the subject and will shed light on other studies on the subject. In this way, it is aimed to draw attention to other researches to be carried out to take the necessary measures and measures against these problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

December 1, 2022

Last Update Submit

March 5, 2024

Conditions

Keywords

anemia in pregrnancyPlacentaRisky PregnancyimmunohistochemistryAging

Outcome Measures

Primary Outcomes (1)

  • %22,2 Patients's placenta with Anemia in Adolescent ( ≤18)Pregnancy and %26,7 Patients's Placenta with from Anemia in Advanced Age (≥35) Pregnancy. Placenta Tissues Staining Measured by immunohistochemistry tecnique.

    DMT1, TFR1 and IRP1 immunohistochemistry results are higher in anemic pregnants compared to non-anemic pregnant women aged ≤18 and ≥35 years. Even if the mother has iron deficiency, the deficiency can be tolerated by the iron absorption mechanism in the placenta.

    Baseline

Study Arms (4)

Group 1:

Anemic pregnancies under the age of 18 (study group),

Group 2:

Anemic pregnancies over the age of 35 (study group)

Group 3:

Pregnant women under the age of 18 are not anemic (control group)

Group 4:

Non-anemic pregnant women over the age of 35 (control group)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

anemic pregnant women under the age of 18, Anemic pregnant women over the age of 35, not anemic pregnant women under age of 18 and not anemic pregnant women over the age of 35

You may qualify if:

  • Clinic diagnosis of anemic pregnancies
  • Pregnant women who have spontaneous vaginal birth
  • Anemia in Adolescent Pregnancy
  • Anemia in Advanced Age Pregnancy

You may not qualify if:

  • multiple pregnancy
  • insulin dependent diabetes
  • pregnant women who have had a cesarean section
  • preeclampsia
  • thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manisa Celal Bayar University

Yunusemre, Mani̇sa, 45030, Turkey (Türkiye)

Location

Manisa Celal Bayar University

Yunusemre, Mani̇sa, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

placenta tissues

MeSH Terms

Conditions

Placenta Diseases

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ada Israfilzade, Researcher asist

    Manisa Celal Bayar University

    STUDY CHAIR
  • Gulsen Gurgen, Assoc.Dr.

    Manisa Celal Bayar University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Prof.

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

February 17, 2021

Primary Completion

February 1, 2023

Study Completion

June 1, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Locations