NCT04756102

Brief Summary

to find out whether variations in the fasting blood glucose in early pregnancy affect the fetomaternal outcome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration 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

January 30, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

February 8, 2021

Last Update Submit

February 13, 2021

Conditions

Maternal Diabetes

Outcome Measures

Primary Outcomes (1)

  • diagnosis of gestational diabetes

    if the pregnant patients was diagnosed to have GDM

    During her pregnancy; an average 20 weeks

Study Arms (2)

FBS lower than 80

Those pregnant patients with FBS less than 80 mg/dl

Other: Observation of their fetomaternal outcome

FBS 80-120

Those pregnant patients with FBS between 80-120

Other: Observation of their fetomaternal outcome

Interventions

Observation of their fetomaternal outcomeOTHER

observe the fetal outcome and maternal outcome

FBS 80-120FBS lower than 80

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women in their first pregnancy

You may qualify if:

  • Pregnant

You may not qualify if:

  • Thyroid disorder
  • Diabetes mellitus
  • Taking Steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Husban University Naser

Amman, 11941, Jordan

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 16, 2021

Study Start

January 30, 2018

Primary Completion

November 30, 2020

Study Completion

December 15, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)