NCT05429242

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

June 11, 2022

Last Update Submit

April 21, 2023

Conditions

Keywords

placental volumeperinatal prognosisfirst trimesterpregnancy

Outcome Measures

Primary Outcomes (4)

  • Placental thickness in millimetres and pregnancy outcomes

    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

    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

    Fetal weight in grams

    Fetal weight at the time of birth from the first three -month period of pregnancy (about 7 months)

  • Pregnancy outcomes

    APGAR scores in numerical values

    At the first minute and 5th minute after delivery

Interventions

Measurement of placental volume at the first trimester of pregnancy by using ultrasound.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \>18 years of age
  • st trimester pregnancy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Üniversity Medical Faculty

Siirt, 56000, Turkey (Türkiye)

Location

Related Publications (3)

  • Vachon-Marceau C, Demers S, Markey S, Okun N, Girard M, Kingdom J, Bujold E. First-trimester placental thickness and the risk of preeclampsia or SGA. Placenta. 2017 Sep;57:123-128. doi: 10.1016/j.placenta.2017.06.016. Epub 2017 Jun 17.

    PMID: 28864000BACKGROUND
  • Effendi M, Demers S, Giguere Y, Forest JC, Brassard N, Girard M, Gouin K, Bujold E. Association between first-trimester placental volume and birth weight. Placenta. 2014 Feb;35(2):99-102. doi: 10.1016/j.placenta.2013.11.015. Epub 2013 Dec 3.

    PMID: 24345759BACKGROUND
  • Farina A. Systematic review on first trimester three-dimensional placental volumetry predicting small for gestational age infants. Prenat Diagn. 2016 Feb;36(2):135-41. doi: 10.1002/pd.4754. Epub 2016 Jan 19.

    PMID: 26618611BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Şerif Aksin, Assoc.Prof

    Siirt University Medical Faculty Obstetrics and Gynecology Departmant

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 11, 2022

First Posted

June 23, 2022

Study Start

June 11, 2022

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations