Glucose Levels in Early Pregnancy and Feto-maternal Outcome

Maternal Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756102
• Other study ID #: the University Of Jordan, Glu
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 15, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Pregnant

Exclusion Criteria:

• Thyroid disorder

• Diabetes mellitus

• Taking Steroids

Related Conditions & MeSH terms

• Diabetes, Gestational
• Maternal Diabetes

Intervention

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

Locations

Country	Name	City	State
Jordan	Al-Husban University Naser	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of gestational diabetes	if the pregnant patients was diagnosed to have GDM	During her pregnancy; an average 20 weeks