NCT04213443

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

December 31, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

December 26, 2019

Last Update Submit

March 13, 2021

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Estimated fetal weight changes.

    Changes in estimated fetal weight during pregnancy.

    Up to 1 year from admission.

Study Arms (1)

Women of short stature

Women that are under 1.6 meters.

Other: Analysis of a patient registry

Interventions

Analysis of a patient registryOTHER

Analysis of a patient registry.

Women of short stature

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women of short stature under 1.6 meters.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2019

First Posted

December 30, 2019

Study Start

December 31, 2020

Primary Completion

February 28, 2021

Study Completion

March 11, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)