The Relation Between Placental Volume at the 1st Trimester and Perinatal Prognosis

April 21, 2023 updated by: Serif Aksin, Siirt University

Placental Thickness and Pregnancy Outcomes

It has been known for years that placental transport and endocrine and metabolic functions of the placenta are the main determinants of fetal nutrition and homeostasis. And placental capacity is roughly related to the weight of this organ. It has long been understood that placental weight at birth is also positively associated with birth weight. Since the 1970s, it has been possible to assess the size of the placenta in early pregnancy using two-dimensional (2D) ultrasonography (USG). Since then, it has been estimated that placental size is associated with fetal development. However, the difficulty in defining the required sonographic planes due to the technology of that time-limited the usefulness of this technique. As studies on this subject increase with the development of technology, it has now been shown that low placental volume at 11-13 weeks is associated with babies small for gestational age (SGA), fetal growth restriction, and preeclampsia. Pregnancy complications place a severe burden on the health system. Detection of these complications in the early period will prevent maternal and fetal mortality and morbidity. A relationship that predicts obstetric, fetal, and perinatal risks with placental thickness and width measurement with USG, a non-invasive method, in an early period such as the 1st trimester, will enable a proactive approach to complications. In our study, the investigators plan to present the perinatal results they obtained rather than investigating a specific relationship. The investigators think that the results of their study will make a profound contribution to the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the relationship between the calculated placental volume in the 1st trimester and poor perinatal outcomes. For this purpose, approximately 360 pregnant women, who were followed up in Siirt Training and Research Hospital between June 2022 and June 2023 and were in their first trimester of pregnancy, will be included in the study. The pregnant woman's age, pregnancy history, and medical history will be recorded. The patient's gestational week, placental volume, and location will be recorded during the examination. All participants will be followed up until delivery. During delivery, gestational week, delivery type, fetal weight, APGAR score, baby gender, and pregnancy outcomes, preeclampsia, Gestational Diabetes, Gestational Hypertensive diseases, Premature rupture of membranes, preterm labor, oligohydramnios, polyhydramnios, presentation anomaly, Intrauterine death, Perinatal fetal disorders such as distress, intrauterine growth retardation, preeclampsia, placental abruption, placental invasion anomaly, placental implantation anomalies, postmaturity will be recorded. In the light of the information gathered, the relationship between placental volume in the 1st trimester and perinatal prognosis will be determined.

Study Type

Observational

Enrollment (Actual)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Siirt, Turkey, 56000
        • Siirt Üniversity Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women over the age of 18 and at 11-14 weeks of pregnancy

Description

Inclusion Criteria:

  • >18 years of age
  • 1.st trimester pregnancy

Exclusion Criteria:

  • history of chronic hypertension
  • history of pre gestational diabetes
  • history of chronic diseases
  • excessive consumption of alcohol
  • smoking pregnants
  • kidney disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental thickness in millimetres and pregnancy outcomes
Time Frame: From the 1.st trimester of pregnancy up to the first month after birth ( the perinatal period,(( about 7 months ))
The relationship between placental volume in the 1st trimester and perinatal prognosis will be tried to be determined.
From the 1.st trimester of pregnancy up to the first month after birth ( the perinatal period,(( about 7 months ))
Pregnancy outcomes
Time Frame: Pregnancy Week at the time of birth from the first three -month period of pregnancy (about 7 months)
Gestational age in weeks during delivery
Pregnancy Week at the time of birth from the first three -month period of pregnancy (about 7 months)
Pregnancy outcomes
Time Frame: Fetal weight at the time of birth from the first three -month period of pregnancy (about 7 months)
Fetal weight in grams
Fetal weight at the time of birth from the first three -month period of pregnancy (about 7 months)
Pregnancy outcomes
Time Frame: At the first minute and 5th minute after delivery
APGAR scores in numerical values
At the first minute and 5th minute after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siirt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2022

Primary Completion (Actual)

April 15, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SiirtUNIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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