Fetal Growth Pattern in Short Stature Women | NCT04213443

Studies
Fetal Growth Pattern in Short Stature Women

NCT04213443

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Intrauterine Growth Restriction

Interventions

Analysis of a patient registry

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2020Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Mar 11, 2021Actual

First Submitted Date

Dec 26, 2019

First Submission Date that Met QC Criteria

Dec 26, 2019

First Posted Date

Dec 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women of short stature		Women that are under 1.6 meters.	Other: Analysis of a patient registry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Analysis of a patient registry	Other	Analysis of a patient registry.	Women of short stature

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women of short stature under 1.6 meters.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roy Lauterbach, MD	Rambam healthcare campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam health care campus		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005317	Fetal Growth Retardation

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided