Pregnancy ComplicationsNCT05429242
The Relation Between Placental Volume at the 1st Trimester and Perinatal Prognosis
An observational study of Pregnancy Complications and Perinatal Problems, run by Siirt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Perinatal Problems, Maternal-Fetal Relations
- What is being tested?
- Ultrasonographic examination
- How many people
- 360 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2022to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women over the age of 18 and at 11-14 weeks of pregnancy
Who may be able to join
- >18 years of age
- 1.st trimester pregnancy
Who cannot join
- history of chronic hypertension
- history of pre gestational diabetes
- history of chronic diseases
- excessive consumption of alcohol
- smoking pregnants
- kidney disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Ultrasonographic examination
- Keywords
- placental volume, perinatal prognosis, first trimester, pregnancy
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examinationOther
Measurement of placental volume at the first trimester of pregnancy by using ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Pregnancy Week at the time of birth from the first three -month period of pregnancy (about 7 months)
Pregnancy outcomes
Fetal weight in grams
Measured: 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
Measured: At the first minute and 5th minute after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start11 Jun 2022
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serif Aksin, Siirt University
- Investigators
- Şerif Aksin, Assoc.Prof, Study director, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429242
- Sponsor's protocol ID
- SiirtUNIV
- Status last verified
- Apr 2023
- First submitted
- 11 Jun 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 28864000Effendi 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 24345759Farina 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Thickness and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT05429242
- Acronym / sponsor ID
- SiirtUNIV
- Keywords
- placental volume, perinatal prognosis, first trimester, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 11 Jun 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women over the age of 18 and at 11-14 weeks of pregnancy
Key inclusion criteria (2 listed)
- >18 years of age
- 1.st trimester pregnancy
Key exclusion criteria (6 listed)
- history of chronic hypertension
- history of pre gestational diabetes
- history of chronic diseases
- excessive consumption of alcohol
- smoking pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic examinationMeasurement of placental volume at the first trimester of pregnancy by using ultrasound. | Other | – |
Primary outcome
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.
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 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
Pregnancy outcomes
Time frame: At the first minute and 5th minute after delivery
APGAR scores in numerical values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 28864000Vachon-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.
- Background: PubMed 24345759Effendi 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.
- Background: PubMed 26618611Farina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerif Aksin, Assoc.Prof study director
Siirt University Medical Faculty Obstetrics and Gynecology Departmant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Perinatal Problems, run by Siirt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05429242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.