Comparison of Three Methods for Fetal Weight Estimation

Comparison of Three Methods of Fetal Weight Estimation in Patients With Severe and Morbid Obesity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Obesity, Morbid; Fetal Weight
• Intervention / Treatment: Other: ultrasonographic fetal weight estimation; Other: clinical fetal weight estimation; Other: maternal subjective fetal weight estimation

Detailed Description

Accuracy of fetal weight estimation is of key importance in antenatal care, as well as in the planning and management of labor and mode of delivery. In order to achieve more accurate prenatal fetal weight estimations and align these with a risk-optimizing mode of delivery, additional tools supporting the standard of use with ultrasound are needed.

The main ultrasonic methods used to calculate the weight of a fetus are based on measurement of fetal abdominal circumference (AC) and estimated fetal weight (EFW) using a formula first described by Hadlock, and the sufficient accuracy of this model has recently been proven.

Leopold's maneuvers have a long-standing tradition in obstetrics and midwifery. By placing both hands on the woman's abdomen the examiner can describe the position of the fetus as well as the level of the uterine fundus and thus detect a disproportion between fetus and the female pelvis. Experienced examiners are able to give a clinical estimation of fetal weight after performing Leopold's maneuvers including symphysis-fundal height and abdominal palpation. Maternal body mass index (BMI) has been shown to affect the accuracy of EFW. For example overweight (BMI>25) patients had found an absolute % error >10% in fetal weight estimation in 42.2% and 24.4% of cases, using Leopold's maneuvers and ultrasound, respectively. Maternal estimation of the fetus weight is as accurate as physicians; clinical estimations, and is advised as a complementary method of assessment. 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.

Pregnant women ≥ 37 weeks and with BMI ≥ 35 with singleton who are admitted before delivery will be offered to participate in the study.

1. A clinical weight estimate will be performed by a trained professional physician using Leopold's maneuvers.
2. An ultrasonographic estimate will be performed in our ultrasound unit and a calculation by the ultrasound machine is based on Hadlock's formula [3] including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).
3. For maternal estimate, patients will be asked to give a fetal weight estimation.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: inshirah sgayer; Phone Number: +972-0508890662; Email: inshirah.sg.sh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant women in term singleton pregnancy

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fetal actual birth weight	fetal actual birth in grams	immediately after delivery

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; term pregnancy; fetal weight estimation; maternal subjective estimation; clinical estimation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Obesity; Body Weight; Obesity, Morbid; Fetal Weight
• Other Study ID Numbers: NHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No