Glucose Levels in Early Pregnancy and Feto-maternal Outcome

Sponsor
University of Jordan (Other)
Overall Status
Completed
CT.gov ID
NCT04756102
Collaborator
(none)
218
1
34.5
6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Observation of their fetomaternal outcome

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
218 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Early Pregnancy Glycemic Levels in Non-diabetic Primigravid Women and Pregnancy Outcome; Retrospective Study
Actual Study Start Date :
Jan 30, 2018
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
FBS lower than 80

Those pregnant patients with FBS less than 80 mg/dl

Other: Observation of their fetomaternal outcome
observe the fetal outcome and maternal outcome

FBS 80-120

Those pregnant patients with FBS between 80-120

Other: Observation of their fetomaternal outcome
observe the fetal outcome and maternal outcome

Outcome Measures

Primary Outcome Measures

  1. diagnosis of gestational diabetes [During her pregnancy; an average 20 weeks]

    if the pregnant patients was diagnosed to have GDM

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant
Exclusion Criteria:
  • Thyroid disorder

  • Diabetes mellitus

  • Taking Steroids

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-Husban University Naser Amman Jordan 11941

Sponsors and Collaborators

  • University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Naser Al-Husban, Assistant Professor, Jordan University Hospital
ClinicalTrials.gov Identifier:
NCT04756102
Other Study ID Numbers:
  • the University Of Jordan, Glu
First Posted:
Feb 16, 2021
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021