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Fetal CPR at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by GDM

Fetal Cerebroplacental Ratio at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by Gestational Diabetes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05852639
Enrollment
260
Registered
2023-05-10
Start date
2022-11-30
Completion date
2024-04-30
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

cerebroplacental ratio, adverse neonatal outcome

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 question\[s\] 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.

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 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: 1. 1&5 minutes APGAR score 2. Neonatal blood glucose 3. Neonatal cord blood PH 4. The need for NICU admission

Interventions

DEVICEUltrasound

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Maternal age: 18-40 years * Diagnosed with gestational DM and are on insulin or metformin treatment. * Single living pregnancy. * Gestational age ≥ 37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).

Exclusion criteria

* Fetal anomalies. * Maternal chronic diseases esp. renal disease, epilepsy or CNS lesion. * Pregnancy induced medical disorders. * IUGR (EFW below the 10th percentile for gestational age). * Rupture of membranes or oligohydramnios (AFI \< the fifth percentile).

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes17 months

Secondary

MeasureTime frame
To evaluate the difference in fetal cerebroplacental ratio in both groups17 months
To evaluate the incidence of adverse neonatal outcome in both groups17 months

Countries

Egypt

Contacts

Primary ContactMariam Gabr
mariam.a.gabr@gmail.com+201227051013
Backup ContactMahmoud Abd El Hameed
+201003457468

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026