Clinical trial NCT05429242: The Relation Between Placental Volume at the 1st Trimester and Perinatal Prognosis
Official title: Placental Thickness and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Perinatal Problems
Maternal-Fetal Relations
Keywords: placental volume
perinatal prognosis
first trimester
pregnancy
Lead sponsor: Siirt University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women over the age of 18 and at 11-14 weeks of pregnancy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Placental thickness in millimetres and pregnancy outcomes
timeFrame: From the 1.st trimester of pregnancy up to the first month after birth ( the perinatal period,(( about 7 months ))
measure: Pregnancy outcomes
timeFrame: Pregnancy Week at the time of birth from the first three -month period of pregnancy (about 7 months)
measure: Pregnancy outcomes
timeFrame: Fetal weight at the time of birth from the first three -month period of pregnancy (about 7 months)
measure: Pregnancy outcomes
timeFrame: At the first minute and 5th minute after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Siirt
country: Turkey
facility: Siirt Üniversity Medical Faculty
Study officials:
affiliation: Siirt University Medical Faculty Obstetrics and Gynecology Departmant
name: Şerif Aksin, Assoc.Prof
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.