NCT02401438

Brief Summary

5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

5.6 years

First QC Date

March 19, 2015

Last Update Submit

July 7, 2020

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

  • Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses

    Sensitivity specificity positive predictive value and negative predictive values will be determined

    72hours

Study Arms (1)

pregnant women with preterm delivery

5D LB and 2D ultrasounds will be done to pregnant women between 28 and 34 weeks planned for termination of pregnancy for obstetric or medical causes.

Other: 5D ultrasoundOther: 2D ultrasound

Interventions

5D ultrasoundOTHER
pregnant women with preterm delivery
2D ultrasoundOTHER
pregnant women with preterm delivery

Eligibility Criteria

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

Pregnant women between 28 and 34 weeks scheduled for termination of pregnancy due to medical or obstetric cause

You may qualify if:

  • to 34 weeks
  • preterm termination of pregnancy
  • singleton pregnancy
  • any obstetric or medical cause for termination of pregnancy

You may not qualify if:

  • IUFD
  • multiple pregnancy
  • congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Mohammed Laban, MD

CONTACT

laban63@yahoo.com

Alaa Hassanin, MD

CONTACT

01002554281alaasayed80@hotmail.com

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 27, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2022

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

EG(1)