NCT02396654

Brief Summary

5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 7, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

March 19, 2015

Last Update Submit

August 4, 2017

Conditions

Fetal Weight

Outcome Measures

Primary Outcomes (1)

  • Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)

    48hours

Study Arms (1)

normal pregnant women

Normal pregnant women between 37 and 42 weeks gestation.

Other: 2D and 5D LB ultrasound comparison for fetal weight estimation

Interventions

2D and 5D LB ultrasound comparison for fetal weight estimationOTHER

2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula. Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight.

normal pregnant women

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Normal pregnant women

You may qualify if:

  • years
  • singleton pregnancy
  • normal pregnancy

You may not qualify if:

  • Intrauterine fetal death
  • multiple pregnancy
  • congenital anomaly
  • nonvisualized fetal parts by ultrasound
  • maternal medical disorders like diabetes and hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

August 7, 2017

Record last verified: 2017-07

Locations

EG(1)