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CompletedNCT05429242Updated Apr 25, 2023

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

An observational study in Pregnancy Complications, Perinatal Problems and Maternal-Fetal Relations, sponsored by Siirt University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Siirt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
360
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Pregnancy Complications
  • Perinatal Problems
  • Maternal-Fetal Relations

Keywords

  • placental volume
  • perinatal prognosis
  • first trimester
  • pregnancy
03

In context

Pregnancy Complications

437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.

This study's enrollment of 360 is above the median of 320 across 205 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Siirt University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
360 participants (actual)
Patient registry
No

Interventions

  • OtherUltrasonographic examination

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the 1.st trimester of pregnancy up to the first month after birth ( the perinatal period,(( about 7 months ))

  2. Pregnancy outcomes

    Gestational age in weeks during delivery

    Time frame: Pregnancy Week at the time of birth from the first three -month period of pregnancy (about 7 months)

  3. Pregnancy outcomes

    Fetal weight in grams

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

  4. Pregnancy outcomes

    APGAR scores in numerical values

    Time frame: At the first minute and 5th minute after delivery

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Study locations

1 site
  • Siirt Üniversity Medical Faculty
    Siirt, 56000, Turkey
08

References and documents

Publications

  • 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. PubMed 28864000 ↗
  • 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. PubMed 24345759 ↗
  • 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. PubMed 26618611 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05429242
Lead sponsor
Siirt University
Responsible party
Serif Aksin (associate professor, Siirt University) — Principal investigator
First posted
Jun 23, 2022
Start date
Jun 11, 2022
Primary completion
Apr 15, 2023
Completion
Apr 15, 2023
Last update
Apr 25, 2023

Study contacts

Şerif Aksin, Assoc.Prof
study director · Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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