Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04756102 |
Other study ID # |
the University Of Jordan, Glu |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 30, 2018 |
Est. completion date |
December 15, 2020 |
Study information
Verified date |
February 2021 |
Source |
University of Jordan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
to find out whether variations in the fasting blood glucose in early pregnancy affect the
fetomaternal outcome
Description:
Retrospective study conducted on the records of patients who were seen at Jordan University
hospital in the period January 2016 to December 2020. All primigravid women with FBS that
were done in early pregnancy before completed 20 weeks of gestation were included. Exclusion
criteria were known diabetics, multiple pregnancies, thyroid dysfunction, patients taking
steroids or any other medications for chronic illness (s) and those with missing data.
Patients were divided into 2 groups; group had a FBS 80-120 mg/dl and group 2 with FBS less
than 80 mg/dl. Pregnancy outcomes were then compared between the 2 groups.
Gestational age was confirmed by early ultra-sound (US) scan before 16 weeks gestation. All
FBS samples were measured at our laboratory. Investigators collected data regarding patients'
age, body mass index (BMI), FBS early in pregnancy, any complication in the pregnancy or the
pregnancy outcome including miscarriage (defined as pregnancy loss before completed 24 weeks
gestation), preterm delivery (defined as spontaneous vaginal delivery before completed 37
weeks gestation), gestational age at delivery, polyhydramnios, congenital abnormality (minor
or major), stillbirth, intra-uterine fetal death (IUFD), neonatal death and mode of delivery.
For those who underwent cesarean section, the indications were also identified. Fetal outcome
included birth weight; APGAR score at 1 minute and APGAR score at 5 minutes. The APGAR score
was determined by the neonatologists who routinely attend deliveries at our hospital.
Investigators also identified those who were diagnosed to have GDM with any intervention
(metformin or insulin and their dosages). Diagnosis of GDM was based on a standard 75 gm
glucose tolerance test (GTT) at 26-28 weeks gestation. A normal FBS level is lower than 95
mg/dL, one hour lower than 180 mg/dL, two hours lower than 155 mg/dL Three hours after
drinking the glucose solution, a normal blood glucose level is lower than 140 mg/dL.