Status unknownNCT03206281TSFWUpdated Jul 2, 2017

Tall Stature Women Fetal Weight Estimation

An observational study in Ultrasonography, Prenatal, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Meir Medical Center · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years to 45 Years
Sex: Female

Study summary

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

Read the 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

Conditions studied

Ultrasonography, Prenatal

Browse trials for

Fetal Weight 22

Keywords

clinical weight estimation

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Pregnant women

Inclusion criteria

Pregnant women above 172 cm height
above 39 weeks of gestation

Exclusion criteria

Exclusion Criteria:

contraindication for vaginal delivery
Intrauterus growth restriction

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 200 participants (estimated)
Target follow-up: 1 Year
Patient registry: Yes

Groups and cohorts

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

Diagnostic testFetal wight estimation
We will estimate the fetal weight by sonographic and clinical estimation

What researchers measure

Primary outcomes

The accuracy of fetal weight estimation
Comparing the sonographic and clinical fetal weight estimation to the actual fetal weight
Time frame: 2 weeks

Secondary outcomes

Mode of delivery and fetal complication
Vaginal Versus cesarian section delivery
Time frame: 2 weeks

Study locations

1 site

Meir Medical Center
Kfar Saba,, 11125, Israel

References and documents

Publications

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. PubMed 34382135 ↗

Individual participant data

Plan to share: Yes — within 6m of finishing the study

Registry details

Key details

Study ID: NCT03206281
Lead sponsor: Meir Medical Center
Responsible party: Yair Daykan (Principal Investigator, M.D, Meir Medical Center) — Principal investigator
First posted: Jul 2, 2017
Start date: Jul 5, 2017 (estimated)
Primary completion: Aug 29, 2018 (estimated)
Completion: Sep 29, 2018 (estimated)
Last update: Jul 2, 2017

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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