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

Pregnancy Complications Clinical Trial

Official title:

Placental Thickness and Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429242
• Other study ID #: SiirtUNIV
• Status: Completed
• Start date: June 11, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: April 2023
• Source: Siirt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal-Fetal Relations
• Perinatal Problems
• Pregnancy Complications

Intervention

Other:
• Ultrasonographic examination
Measurement of placental volume at the first trimester of pregnancy by using ultrasound.

Locations

Country	Name	City	State
Turkey	Siirt Üniversity Medical Faculty	Siirt

Sponsors (1)

Lead Sponsor	Collaborator
Siirt University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ))
Primary	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)
Primary	Pregnancy outcomes	Fetal weight in grams	Fetal weight at the time of birth from the first three -month period of pregnancy (about 7 months)
Primary	Pregnancy outcomes	APGAR scores in numerical values	At the first minute and 5th minute after delivery