Fetal Macrosomia, Intrauterine Growth Restriction, Pregnancy
Conditions
Brief summary
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.
Detailed description
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)
Interventions
RADIATIONultrasound
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
Sponsors
Ain Shams University
Ain Shams Maternity Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. patient Aged between 18 and 45 years. 2. singleton viable pregnancy. 3. non scared uterus.
Exclusion criteria
1. systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease) 2. known congenital fetal anomalies. 3. multiple pregnancy. 4. intra uterine fetal death. 5. anatomical defect of pregnant uterus 6. abnormally located placenta or placental anomalies 7. morbid obesity 8. missing records 9. unwilling to incorporate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Weight (Fetal Weight at Birth) | 9 months | Fetal weight (fetal weight at birth) (in grams) |
| Placental Thickness in Second Trimester | 15-20 weeks of gestation | placental thickness measured in millimeter |
| Placental Thickness at 3rd Trimester | 30-34 weeks of pregnancy | — |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 395 |
| Total | 395 |
Baseline characteristics
| Characteristic | Pregnant Women |
|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 3 |
| Height | 1.7 Meter STANDARD_DEVIATION 0.07 |
| Sex: Female, Male Female | 395 Participants |
| Sex: Female, Male Male | 0 Participants |
| weight | 78 kg STANDARD_DEVIATION 12 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 395 |
| serious Total, serious adverse events | 0 / 395 |
Outcome results
Primary
Fetal Weight (Fetal Weight at Birth)
Fetal weight (fetal weight at birth) (in grams)
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women | Fetal Weight (Fetal Weight at Birth) | 3243 gram | Standard Deviation 402 |
Primary
Placental Thickness at 3rd Trimester
Time frame: 30-34 weeks of pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women | Placental Thickness at 3rd Trimester | 35.6 millimeter | Standard Deviation 4.1 |
Comparison: Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.p-value: <0.01Regression, Linear
Primary
Placental Thickness in Second Trimester
placental thickness measured in millimeter
Time frame: 15-20 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women | Placental Thickness in Second Trimester | 21.5 millimeter | Standard Deviation 2.5 |
Comparison: Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.p-value: <0.01Regression, Linear