Clinical trial NCT02473991: Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
Official title: Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Fetal Macrosomia
Intrauterine Growth Restriction
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2015-06-17
Enrollment: 395
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: uncomplicated pregnant women who will attend the outpatient clinic at Ain Shams University Maternity Hospital

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Fetal Weight (Fetal Weight at Birth)
timeFrame: 9 months
measure: Placental Thickness in Second Trimester
timeFrame: 15-20 weeks of gestation
measure: Placental Thickness at 3rd Trimester
timeFrame: 30-34 weeks of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams faculty of medicine
state: Elabbasia
Study officials:
affiliation: Ain Shams University
name: AHMED MEKLED, Professor
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: HAYTHAM SABAA, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.