Fetal Clavicular Measurement to Predict Fetal Macrosomia

February 27, 2024 updated by: Khaled Mustafa Attyia, Assiut University

Fetal Clavicular Measurement to Predict Fetal Macrosomia: A Prospective Cohort Study

Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.

The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Two terms are applied for fetal overgrowth, Large for gestational age (LGA) meaning fetal birth weight (BW) more than 90th percentile for specific gestational age while macrosomia is an absolute value regardless of gestational age which historically defined as 4000-4500 gm. Those two groups have increased risks for neonatal and maternal complications compared to general population and increase sharply when BW >4500gm, the risks of macrosomia are continuum without threshold defining safe and risky outcome, some authors classify macrosomia into 3 grades, grade 1 (4000gm-4499gm), grade 2(4500-4999), grade 3 (≥5000gm).

Despite its implications, the accurate diagnosis is after birth and its prenatal prediction is poor although published formulas for estimating fetal weight shows correlation with BW, however the variability of the estimate is up to 20% with most of formulas, meta-analysis of 29 studies showed sensitivity of 56% and specificity of 92% in predicting BW ≥ 4000gm accuracy of ultrasound decreases with increasing BW, BW>4500 accurate prediction is only 33-44 % of cases. Given the poor predictability of macrosomia, variety of other techniques and formulas are investigated, neither repeated US examination nor growth curves improves predictability, Youssef's formula measuring biacromial diameter (distance by between both acromial processes which joins clavicles at acromioclavicular joints) and macrosomic specific formula seems to be predictive. In study evaluating clavicle length for shoulder dystocia, it found that measuring clavicle was significant for macrosomia however the limitation is small sample size and its comparison with other fetal biometrics may be needed.

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

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

Study Contact

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

pregnant women with gestational age between 37 weeks and 42 weeks

Description

Inclusion Criteria:

  • Singleton pregnancy.
  • Gestational age between 37-42 weeks.
  • Accepting to be included in the study.

Exclusion Criteria:

  • Congenital fetal malformation affecting birth weight or affecting clavicle.

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
Singleton pregnant women at gestational age between 37-42 weeks
estimated fetal weight measured by ultrasound using Hadlock IV formula and Youssef's formula compared with the sensitivity of fetal clavicular measurement.
Device: Obstetric Ultrasound
Measuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Third trimester clavicle length measurement
Time Frame: 37-42 weeks of gestation
Sensitivity of third trimester clavicle length measurement in comparison with biacromial diameter and Hadlock IV formula in predicting fetal macrosomia
37-42 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish the relationship between third-trimester clavicle length and shoulder dystocia
Time Frame: Immediately after delivery - postprocedure
establishing if clavicle length is predictive of shoulder dystocia or not.
Immediately after delivery - postprocedure
Mode of delivery
Time Frame: At the day of delivery
either vaginal delivery or Cesarean section
At the day of delivery
Gestational age at the time of delivery.
Time Frame: At the day of delivery
gestational age and its relation to birth weight
At the day of delivery
Neonatal Apgar score.
Time Frame: postpartum with 1 and 5 minutes
neonatal health evaluation
postpartum with 1 and 5 minutes
Neonatal bi-acromial diameter
Time Frame: postpartum within 1 to 5 minutes
measuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.
postpartum within 1 to 5 minutes
Neonatal birth weight
Time Frame: postpartum within 1 to 5 minutes
neonatal nurse measuring actual neonatal birth weght in grams using digital scale.
postpartum within 1 to 5 minutes
Neonatal need for NICU
Time Frame: postpartum within 1 minutes to 5 minutes
need for neonatal ICU
postpartum within 1 minutes to 5 minutes
Neonatal actual clavicle length
Time Frame: postpartum within 1 minutes to 5 minutes
measuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.
postpartum within 1 minutes to 5 minutes

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Alaa ElDin Abdelhamid Yusef Hasan, Emeritus Professor of obstetrics and gynecology
  • Study Director: Ahmed Mohamed Abbas Sobh, Assistant Professor of obstetrics and gynecology
  • Study Director: Mohamed Mahmoud Abdallah Mahmoud, Lecturer of obstetrics and gynecology

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fetal macrosomia

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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