NCT05478798

Brief Summary

The aim of this study was to compare maternal, clinical and ultrasound estimations of fetal weight in women with severe (BMI\>35) and morbid (BMI\>40) obesity and to determine the effect of maternal body mass index (BMI) on these estimations.

Trial Health

35
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 Aug 2022

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

July 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

July 25, 2022

Last Update Submit

July 25, 2022

Conditions

Keywords

fetal weight estimationultrasoundmaternal subjective estimationterm pregnancyclinical estimation

Outcome Measures

Primary Outcomes (1)

  • fetal actual birth weight

    fetal actual birth in grams

    immediately after delivery

Interventions

An ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).

A clinical weight estimate will be performed by using Leopold's maneuvers

the pregnant woman will tell her subjective estimation of fetal weight estimation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women in term singleton pregnancy

You may qualify if:

  • Pregnant women ≥ 37 weeks
  • BMI ≥ 35
  • Singleton pregnancies
  • Fetal weight estimate within two weeks from delivery

You may not qualify if:

  • Primiparity
  • Women who will give birth in a different hospital
  • Multiple pregnancy
  • Moderate to severe polyhydramnios
  • Severe fetal malformations - such as hydrocephalus, hydrops fetalis
  • Maternal age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sgayer I, Francis YN, Ashkar-Majadla N, Tuma R, Lowenstein L, Frank Wolf M, Odeh M. Three Methods of Fetal Weight Estimation Compared in Women With BMI >/= 35 kg/m2 at Term-A Prospective Observational Study. Birth. 2025 Nov 25. doi: 10.1111/birt.70041. Online ahead of print.

MeSH Terms

Conditions

Fetal WeightObesity, Morbid

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Inshirah Sgayer

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 28, 2022

Study Start

August 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

July 28, 2022

Record last verified: 2022-07