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

• ClinicalTrials.gov Identifier: NCT02473991
• Recruitment Status: Completed
• First Posted: June 17, 2015
• Results First Posted: August 2, 2017
• Last Update Posted: August 2, 2017
• Sponsor: Ain Shams Maternity Hospital
• Collaborator: Ain Shams University
• Information provided by (Responsible Party): amr elsayed elsayed, Ain Shams Maternity Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Pregnancy; Fetal Macrosomia; Intrauterine Growth Restriction	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 Design

• Study Type: Observational
• Actual Enrollment: 395 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
• Study Start Date: March 2015
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: January 2017

Groups and Cohorts

Intervention Details:

• Radiation: ultrasound
  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

Outcome Measures

Primary Outcome Measures :

1. Fetal Weight (Fetal Weight at Birth) [ Time Frame: 9 months ]
   Fetal weight (fetal weight at birth) (in grams)
2. Placental Thickness in Second Trimester [ Time Frame: 15-20 weeks of gestation ]
   placental thickness measured in millimeter
3. Placental Thickness at 3rd Trimester [ Time Frame: 30-34 weeks of pregnancy ]

Biospecimen Retention:   Samples Without DNA

placenta is weighed in grams as described by Azpurua et al.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 30 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

Egypt

Ain shams faculty of medicine

Cairo, Elabbasia, Egypt

Sponsors and Collaborators

Ain Shams Maternity Hospital

Ain Shams University

Investigators

• Study Director: AHMED MEKLED, Professor; Ain Shams University
• Study Director: HAYTHAM SABAA, Lecturer; Ain Shams University

More Information

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.

• Responsible Party: amr elsayed elsayed, researcher for master degree, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT02473991
• Other Study ID Numbers: Master degree in Obs & gyn
• First Posted: June 17, 2015
• Results First Posted: August 2, 2017
• Last Update Posted: August 2, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Fetal Growth Retardation; Fetal Macrosomia; Fetal Weight; Fetal Diseases; Pregnancy Complications; Growth Disorders; Pathologic Processes; Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight