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The goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question[s] it aims to answer are:
Participants will undergo ultrasound and doppler study at 37 weeks & every two weeks thereafter till delivery. Neonatal assessment will be done after delivery to exclude adverse outcomes.
pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment. Informed consent, to share in the study, will be taken from all participants after describing the aim of the study and the potential hazards.
The patients enrolled in our study will be divided into two equal groups according to their treatment regimens:
(Group A): 130 patients who are on insulin treatment
(Group B): 130 patients who are on metformin
*All participants will be subjected to the following:
A) Full history taking:
Including personal, menstrual, obstetric, present, past & family history. B) Complete Physical Examination (general & local).
C) Investigations:
Routine baseline investigations:
Doppler ultrasonography assessment:
Doppler study and Cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks.To reduce inter-operator variability, a single experienced sonographer will perform all sonograms.
The mode of delivery and the gestational age at delivery will be noted
Early neonatal assessment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin | patients on insulin treatment for gestational diabetes |
| |
| Metformin | patients on metformin treatment for gestational diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Routine obstetric ultrasound will be done at term (at 37 weeks gestation): to confirm gestational age, assess fetal weight and amniotic fluid index and to exclude fetal anomalies.Doppler study and cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes | 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the difference in fetal cerebroplacental ratio in both groups | 17 months | |
| To evaluate the incidence of adverse neonatal outcome in both groups | 17 months |
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Inclusion Criteria:
Exclusion Criteria:
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The patients in our study will be recruited from Kasr al-Ainy hospital inpatient departments as follows: pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariam Gabr | Contact | +201227051013 | mariam.a.gabr@gmail.com | |
| Mahmoud Abd El Hameed | Contact | +201003457468 |
| Name | Affiliation | Role |
|---|---|---|
| Mariam Gabr | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr al-ainy hospital, Faculty of Medicine - Cairo University | Recruiting | Cairo | 11451 | Egypt |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |