Glucose Levels in Early Pregnancy and Feto-maternal Outcome

Early Pregnancy Glycemic Levels in Non-diabetic Primigravid Women and Pregnancy Outcome; Retrospective Study

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

Study Overview

• Status: Completed
• Conditions: Maternal Diabetes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • Al-Husban University Naser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in their first pregnancy

Description

Inclusion Criteria:

• Pregnant

Exclusion Criteria:

• Thyroid disorder
• Diabetes mellitus
• Taking Steroids

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of gestational diabetes	if the pregnant patients was diagnosed to have GDM	During her pregnancy; an average 20 weeks

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: the University Of Jordan, Glu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No