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| Name | Class |
|---|---|
| Ain Shams University | OTHER |
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The aim of this prospective longitudinal study was to investigate the relationship between placental thickness during the second and third trimesters and placental and birth weights.
The investigator will make certain that the appropriate informed consent process is in place to ensure that potential research subjects, or their authorized representatives, are fully informed about the nature and objectives of the study, the potential risk and benefits of study participation, and their right as research subjects.
All laboratory specimens, evaluation forms, reports, video recordings, and other records that leave the site will not include unique personal data to maintain subject confidentiality.
All patients provided an informed written consent after they were fully instructed about the investigation.The study was approved by ethical committee of Ain Shams University.
All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, parity, body mass index (BMI) and past medical events. Smoking, alcohol and drug use were also determined.
At second and third trimester (15-20 and 30-34 weeks of gestation respectively), the maternal weight, weight gain, BMI, BMI gain and data of ultrasound examination were recorded. At the time of delivery after assessment of maternal weight as mentioned above, the birth weight (in grams), fetal sex, and mode of delivery were taken.
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).
All sonographic examinations were performed trans-abdominal using a Medison X4 ultrasound machine Trans abdominal4.0 megahertz (MHz) probe at The Special Care Center for Fetus Unit at Ain Shams University Maternity Hospital.
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al
Each evaluation was performed by one of two experienced sonographers of our hospital with minimum inter- and intra-observer variability.
After delivery, the placenta was weighed in grams as previously described by Azpurua et al.
Fetal weight (primary objective) and neonatal status and morbidity including baby Apgar scores, fetal distress or fetal death and admission to the neonatal intensive care unit were also determined. All the examinations and data recording were performed by two senior resident physicians.(secondary objective)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound | Radiation | The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Weight (Fetal Weight at Birth) | Fetal weight (fetal weight at birth) (in grams) | 9 months |
| Placental Thickness in Second Trimester | placental thickness measured in millimeter | 15-20 weeks of gestation |
| Placental Thickness at 3rd Trimester | 30-34 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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uncomplicated pregnant women who will attend the outpatient clinic at Ain Shams University Maternity Hospital
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| Name | Affiliation | Role |
|---|---|---|
| AHMED MEKLED, Professor | Ain Shams University | Study Director |
| HAYTHAM SABAA, Lecturer | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams faculty of medicine | Cairo | Elabbasia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19653142 | Background | Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, Kliman HJ. Determination of placental weight using two-dimensional sonography and volumetric mathematic modeling. Am J Perinatol. 2010 Feb;27(2):151-5. doi: 10.1055/s-0029-1234034. Epub 2009 Aug 3. | |
| 3903201 | Background | Hoddick WK, Mahony BS, Callen PW, Filly RA. Placental thickness. J Ultrasound Med. 1985 Sep;4(9):479-82. doi: 10.7863/jum.1985.4.9.479. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women | All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women | All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | the age of participant was between 20 years and 30 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fetal Weight (Fetal Weight at Birth) | Fetal weight (fetal weight at birth) (in grams) | Posted | Mean | Standard Deviation | gram | 9 months |
|
adverse event data collection was about 9 months ( time between starting antenatal care and end delivery )
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women | All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| prof Dr khaled ebrahim abdalla | ain shams university maternity hospital | 00201023220701 | drkhaled_abdallah@med.asu.edu.eg |
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| ID | Term |
|---|---|
| D005320 | Fetal Macrosomia |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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placenta is weighed in grams as described by Azpurua et al.
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | Meter |
|
|
|
| Primary | Placental Thickness in Second Trimester | placental thickness measured in millimeter | Posted | Mean | Standard Deviation | millimeter | 15-20 weeks of gestation |
|
|
|
|
| Primary | Placental Thickness at 3rd Trimester | Posted | Mean | Standard Deviation | millimeter | 30-34 weeks of pregnancy |
|
|
|
|
| 0 |
| 395 |
| 0 |
| 395 |
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| D005315 | Fetal Diseases |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D055585 |
| Physical Phenomena |