NCT02473991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 2, 2017

Completed
Last Updated

August 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

May 10, 2015

Results QC Date

January 17, 2017

Last Update Submit

April 21, 2017

Conditions

PregnancyFetal MacrosomiaIntrauterine Growth Restriction

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

ultrasoundRADIATION

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

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams faculty of medicine

Cairo, Elabbasia, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 19653142BACKGROUND

  • 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.

    PMID: 3903201BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Fetal MacrosomiaFetal Growth Retardation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Diabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGrowth DisordersPathologic Processes

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Results Point of Contact

Title
prof Dr khaled ebrahim abdalla
Organization
ain shams university maternity hospital
drkhaled_abdallah@med.asu.edu.eg
00201023220701

Study Officials

  • AHMED MEKLED, Professor

    Ain Shams University

    STUDY DIRECTOR

  • HAYTHAM SABAA, Lecturer

    Ain Shams University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher for master degree

Study Record Dates

First Submitted

May 10, 2015

First Posted

June 17, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 2, 2017

Results First Posted

August 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)