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

NCT05852639 | Unknown

• 1 other identifier: MD-329-2022
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

cerebroplacental ratio; adverse neonatal outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Insulin

patients on insulin treatment for gestational diabetes

Device: Ultrasound

Metformin

patients on metformin treatment for gestational diabetes

Device: Ultrasound

Interventions

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

Insulin; Metformin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr al-ainy hospital, Faculty of Medicine - Cairo University

Cairo, 11451, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mariam Gabr

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Gabr

CONTACT

+201227051013; mariam.a.gabr@gmail.com

Mahmoud Abd El Hameed

CONTACT

+201003457468

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: November 30, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

EG (1)