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Anemia PregnancyNCT05644964

The Effect of Anemia in Adolescent and Advanced Age Pregnancies

An observational study of Anemia Pregnancy and Placenta Diseases, run by Manisa Celal Bayar University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anemia Pregnancy, Placenta Diseases
How many people
80 participants
Where
2 sitesTurkey (Türkiye)
Study dates
17 Feb 2021to 1 Jun 2023
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Manisa Celal Bayar University

    Yunusemre, Mani̇sa, 45030

  • Manisa Celal Bayar University

    Yunusemre, Mani̇sa

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Anemia in Adolescent and Advanced Age Pregnancies on the Tissue of the Placenta

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

Read more

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.

Keywords
anemia in pregrnancy, Placenta, Risky Pregnancy, immunohistochemistry, Aging
Medical subject headings
Placenta Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05644964
Study groupRoleWhat they receive
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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start17 Feb 2021
  3. Primary completion1 Feb 2023
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
80 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644964
Sponsor's protocol ID
MCBU_anemia
Status last verified
Mar 2024
First submitted
1 Dec 2022
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia Pregnancy and Placenta Diseases, run by Manisa Celal Bayar University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

%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. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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