NCT03206281

Brief Summary

To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile)

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

June 20, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2018

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

June 20, 2017

Last Update Submit

June 30, 2017

Conditions

Ultrasonography, Prenatal

Keywords

clinical weight estimation

Outcome Measures

Primary Outcomes (1)

  • The accuracy of fetal weight estimation

    Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight

    2 weeks

Secondary Outcomes (1)

  • Mode of delivery and fetal complication

    2 weeks

Study Arms (2)

Clinical fetal weight estimation

The fetal weight estimation will be taken by professional obstetrician durin her 39 week

Diagnostic Test: Fetal wight estimation

Sonographic fetal weight estimation

The fetal weight estimation will be taken by professional Sonographic obstetrician durin her 39 week

Diagnostic Test: Fetal wight estimation

Interventions

Fetal wight estimationDIAGNOSTIC_TEST

We will estimate the fetal weight by sonographic and clinical estimation

Clinical fetal weight estimationSonographic fetal weight estimation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women obove 172 cm hight
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • Pregnant women above 172 cm height
  • above 39 weeks of gestation

You may not qualify if:

  • contraindication for vaginal delivery
  • Intrauterus growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 11125, Israel

Location

Related Publications (1)

  • Daykan Y, Shavit M, Yagur Y, Schreiber H, Weitzner O, Schonman R, Biron-Shental T, Markovitch O. Fetal weight estimation in tall women: is ultrasound more accurate than clinical assessment? A prospective trial. Arch Gynecol Obstet. 2022 Mar;305(3):567-572. doi: 10.1007/s00404-021-06177-6. Epub 2021 Aug 11.

    PMID: 34382135DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D

Study Record Dates

First Submitted

June 20, 2017

First Posted

July 2, 2017

Study Start

July 5, 2017

Primary Completion

August 29, 2018

Study Completion

September 29, 2018

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

within 6m of finishing the study

Locations

IL(1)