Fetal Growth Pattern in Short Stature Women

Fetal Growth Pattern in Short Stature Women as a Model for True Intrauterine Growth Restriction Prediction.

Women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.

Study Overview

• Status: Completed
• Conditions: Intrauterine Growth Restriction
• Intervention / Treatment: Other: Analysis of a patient registry

Detailed Description

Based on a patient registry, women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.

Informed consent is not required due to the retrospective nature of the study. Patient information including medical, obstetric and general background will be collected.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women of short stature under 1.6 meters.

Description

Inclusion Criteria:

• Women under 1.6 meters of height.
• Singleton pregnancy.
• Low risk pregnancy.
• Accurate dating.

Exclusion Criteria:

• Women over 1.6 meters of height.
• Multiple pregnancy.
• High risk pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women of short stature; Women that are under 1.6 meters.	Other: Analysis of a patient registry; Analysis of a patient registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated fetal weight changes.	Changes in estimated fetal weight during pregnancy.	Up to 1 year from admission.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 11, 2021

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: December 26, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Fetal Diseases; Pregnancy Complications; Growth Disorders; Bone Diseases, Developmental; Fetal Growth Retardation; Dwarfism
• Other Study ID Numbers: 0275-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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