Are There Any Clinical Benefits to Screening for Late -Onset Gestational Diabetes Mellitus?"
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorIzmir Ataturk Training and Research Hospital
About this trial
This study aims to screen women who have a negative Gestational diabetes mellitus (GDM) result in routine screening tests or who have never had it with the Fasting Blood Glucose Test (FBG) at 32-34 weeks of gestation to diagnose late-onset GDM with routine FBG ≥5.1 mmol/L (92mg/dl) in fasting blood, and to investigate its connection with perinatal and maternal outcomes, hoping to inform about late-stage GDM.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Gestational Age: Confirmed singleton pregnancy between 32+0 and 34+6 weeks of gestation based on the last menstrual period (LMP) and/or first-trimester crown-rump length (CRL) ultrasound measurement.
Disqualifiers
Multifetal pregnancies (e.g., twins, triplets) Fetal Anomalies Pre-gestational Chronic Diseases Protocol Non-compliance / Loss to Follow-up Preterm Birth / Preterm Labor
Trial population
The study population consists of pregnant women aged 18 to 45 years with confirmed singleton pregnancies between 32+0 and 34+6 weeks of gestation, presenting for routine antenatal care at the Obstetrics and Gynecology Outpatient Clinic of izmir katip çelebi atatürk Training and Research . Participants are selected from low-to-moderate risk antenatal admissions and will be followed prospectively through labor, delivery, and the postpartum/neonatal period to assess maternal and perinatal outcomes.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
128 Participants
are grouped into 2 trial groupsGroup A: late-onset gestational diabetes mellitus
Group B: control
Trial outcomes
Primary outcomes
1
Rate of NICU admission
the proportion of newborns who require admission to the neonatal ıntensive care unit following delivery
Time frame
from birth up to hospital discharge assessed up to 7 days of life2
Incidence of Macrosomia and Large for Gestational Age (LGA) Infants
The proportion of neonates born with a birth weight of ≥4000 grams (macrosomia) or with a birth weight above the 90th percentile for their gestational age (LGA)
Time frame
At birth3
Incidence of Hypertensive Disorders of Pregnancy (HDCP)
The number of pregnant women who develop preeclampsia or gestational hypertension during the follow-up period
Time frame
From enrollment (32-34 weeks of gestation) up to deliverySecondary outcomes
1
Mode of Delivery and Need for Emergency Cesarean Section
The distribution of delivery modes including normal spontaneous vaginal delivery (NSVD), elective cesarean section, and emergency cesarean section, as well as the need for labor induction
Time frame
At delivery2
Incidence of Shoulder Dystocia and Maternal Lacerations
The percentage of deliveries complicated by shoulder dystocia, and the presence of maternal perineal lacerations
Time frame
At deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov