Glucose Levels in Early Pregnancy and Feto-maternal Outcome

Completed

• Conditions: Maternal Diabetes
• Interventions: Other: Observation of their fetomaternal outcome

• Registration Number: NCT04756102
• Lead Sponsor: University of Jordan

Brief Summary

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

• Study Start: 2018-01-30
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-13
• Last Update Submitted: 2021-02-13
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

Inclusion Criteria

• Pregnant

Exclusion Criteria

• Thyroid disorder
• Diabetes mellitus
• Taking Steroids

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FBS 80-120	Observation of their fetomaternal outcome	Those pregnant patients with FBS between 80-120
FBS lower than 80	Observation of their fetomaternal outcome	Those pregnant patients with FBS less than 80 mg/dl

Primary Outcome Measures

Name	Time	Method
diagnosis of gestational diabetes	During her pregnancy; an average 20 weeks	if the pregnant patients was diagnosed to have GDM

Trial Locations

Locations (1)

Al-Husban University Naser; 🇯🇴 Amman, Jordan