Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852639
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-05-02
Brief Title:
Fetal CPR at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by GDM
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Fetal Cerebroplacental Ratio at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by Gestational Diabetes
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 questions it aims to answer are
To evaluate the efficacy sensitivity specificity of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin those on metformin
to evaluate the incidence of adverse neonatal outcome in patients treated by insulin those on metformin
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
To evaluate the efficacy sensitivity specificity of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin those on metformin
to evaluate the incidence of adverse neonatal outcome in patients treated by insulin those on metformin
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
Detailed Description:
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
1 Complete blood picture Rh typing liver kidney functions
2 HbA1C estimation
3 Surveillance of maternal diabetes daily fasting and 2- hour postprandial capillary glucose measurement
4 Routine obstetric ultrasound will be done at term at 37 weeks gestation to confirm gestational age assess fetal weight EFW and amniotic fluid index AFI and to exclude fetal anomalies
Doppler ultrasonography assessment
Doppler study and Cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeksTo 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
1 15 minutes APGAR score
2 Neonatal blood glucose
3 Neonatal cord blood PH
4 The need for NICU admission
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
1 Complete blood picture Rh typing liver kidney functions
2 HbA1C estimation
3 Surveillance of maternal diabetes daily fasting and 2- hour postprandial capillary glucose measurement
4 Routine obstetric ultrasound will be done at term at 37 weeks gestation to confirm gestational age assess fetal weight EFW and amniotic fluid index AFI and to exclude fetal anomalies
Doppler ultrasonography assessment
Doppler study and Cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeksTo 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
1 15 minutes APGAR score
2 Neonatal blood glucose
3 Neonatal cord blood PH
4 The need for NICU admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None