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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03206281
Other study ID # MMC-0016-17
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 20, 2017
Last updated June 30, 2017
Start date July 5, 2017
Est. completion date September 29, 2018

Study information

Verified date June 2017
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 29, 2018
Est. primary completion date August 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Pregnant women above 172 cm height

- above 39 weeks of gestation

Exclusion Criteria:

- contraindication for vaginal delivery

- Intrauterus growth restriction

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Fetal wight estimation
We will estimate the fetal weight by sonographic and clinical estimation

Locations

Country Name City State
Israel Meir Medical Center Kfar Saba,

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The accuracy of fetal weight estimation Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight 2 weeks
Secondary Mode of delivery and fetal complication Vaginal Versus cesarian section delivery 2 weeks
See also
  Status Clinical Trial Phase
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Completed NCT04399408 - Instinctâ„¢ Ultrasound Device Safety, Efficacy and Usability N/A
Completed NCT04441866 - Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound N/A