Tall Stature Women Fetal Weight Estimation (TSFW)

June 30, 2017 updated by: Yair Daykan, Meir Medical Center

Tall Stature Women Fetal Weight Estimation,Clinical Versus Sonographic Estimation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women undergoing delivery after week 39 will be estimated of their fetal wight with clinical estimation and then sonographic estimation.

each women will be case control 1:1 for the actual fetal weight of the delivery.

the fetal weight will be blinded for each estimation.

Primary outcome is the actual fetal weight Secondary outcomes will be mode of delivery, fetal complication as APGAR score and fetal hypoxia and maternal complication as perineal laceration

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba,, Israel, 11125
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication for vaginal delivery
  • Intrauterus growth restriction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical fetal weight estimation
The fetal weight estimation will be taken by professional obstetrician durin her 39 week
Diagnostic test: Fetal wight estimation
We will estimate the fetal weight by sonographic and clinical 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
We will estimate the fetal weight by sonographic and clinical estimation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of fetal weight estimation
Time Frame: 2 weeks
Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery and fetal complication
Time Frame: 2 weeks
Vaginal Versus cesarian section delivery
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 5, 2017

Primary Completion (ANTICIPATED)

August 29, 2018

Study Completion (ANTICIPATED)

September 29, 2018

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-0016-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

within 6m of finishing the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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