NCT04515823

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,085

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 13, 2020

Last Update Submit

August 16, 2020

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Performing the OGTT test during the pregnancy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

  • Rinat Gabbay-Benziv, M.D

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

April 26, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

IL(1)