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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02473991
• Other study ID #: Master degree in Obs & gyn
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2015
• Last updated: June 13, 2015
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2015
• Source: Ain Shams Maternity Hospital
• Contact: khalid ABDALLA, professor
• Email: drkhaled_abdallah[@]med.asu.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial 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.

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.12.

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.2.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 395
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Fetal Macrosomia
• Fetal Weight
• Intrauterine Growth Restriction
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams faculty of medicine	Cairo	Elabbasia

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal weight	Fetal weight (fetal weight at birth)	9 months	Yes
Secondary	neonatal status	Baby Apgar scores	at time of birth	Yes