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Completed

NCT Number: NCT02473991

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient Aged between 18 and 45 years.
  • singleton viable pregnancy.
  • non scared uterus.

Exclusion criteria

  • systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease)
  • known congenital fetal anomalies.
  • multiple pregnancy.
  • intra uterine fetal death.
  • anatomical defect of pregnant uterus
  • abnormally located placenta or placental anomalies
  • morbid obesity
  • missing records
  • unwilling to incorporate in the study.

Treatment and study plan

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Collaborators

  • Ain Shams University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 17, 2015
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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