Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Intrauterine Growth Restriction; Fetal Macrosomia
• Intervention / Treatment: Radiation: ultrasound

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)

• Study Type: Observational
• Enrollment (Actual): 395

Contacts and Locations

Study Locations

• Egypt
  • Elabbasia
    • Cairo, Elabbasia, Egypt
      • Ain Shams Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

uncomplicated pregnant women who will attend the outpatient clinic at Ain Shams University Maternity Hospital

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Collaborators: Ain Shams University
• Investigators: Study Director: AHMED MEKLED, Professor, Ain shams university; Study Director: HAYTHAM SABAA, Lecturer, Ain shams university

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 10, 2015
• First Submitted That Met QC Criteria: June 13, 2015
• First Posted (Estimate): June 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Body Weight; Fetal Diseases; Pregnancy Complications; Growth Disorders; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Fetal Growth Retardation; Fetal Macrosomia; Fetal Weight
• Other Study ID Numbers: Master degree in Obs & gyn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No