Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy | NCT04515823

Studies
Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy

NCT04515823

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Aug 19, 2020Actual

Enrollment

2,085Actual

Phase

Not provided

Conditions

Pregnancy Related

Interventions

Not provided

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

Aug 2020

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

Apr 26, 2020Actual

Primary Completion Date

Aug 1, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

Aug 13, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 17, 2020Actual

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

Aug 16, 2020

Last Update Posted Date

Aug 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of the study is to examine the relationship between "flat" sugar curve on OGTT-glucose tolerance test during pregnancy, neonatal birthweight and other perinatal outcomes.

Detailed Description

A retrospective cohort analysis of all women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.

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

2,085Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the characteristics and perinatal outcomes of parturients with a flat glucose curve on 100 grams oral glucose tolerance test (OGTT).	A flat OGTT curve occurs in a younger, leaner population. Although flat OGTT can possibly reflect some degree of hyperinsulinemia, it is generally not associated with adverse maternal or neonatal outcomes.	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Performing the OGTT test during the pregnancy

Exclusion Criteria:

lack of documentation or Non-performance of OGTT test during the pregnancy.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

All women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rinat Gabbay-Benziv, M.D	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center		Hadera		38100	Israel