Glucose Levels in Early Pregnancy and Feto-maternal Outcome

NCT ID: NCT04756102

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 218 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2020-12-15

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.

Conditions

Maternal Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

FBS lower than 80

Those pregnant patients with FBS less than 80 mg/dl

Observation of their fetomaternal outcome

Intervention Type: OTHER

observe the fetal outcome and maternal outcome

FBS 80-120

Those pregnant patients with FBS between 80-120

Observation of their fetomaternal outcome

Intervention Type: OTHER

observe the fetal outcome and maternal outcome

Interventions

Observation of their fetomaternal outcome

observe the fetal outcome and maternal outcome

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant

Exclusion Criteria

• Thyroid disorder
• Diabetes mellitus
• Taking Steroids

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Naser Al-Husban

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Husban University Naser

Amman, , Jordan

Countries

Jordan

Other Identifiers

the University Of Jordan, Glu

Identifier Type: -

Identifier Source: org_study_id