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Middle Cerebral and Umbilical Arteries Doppler Indices in the Prediction of Adverse Neonatal Outcome Among Diabetic Pregnant Women

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
umbilical and middle cerebral artery Doppler
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1 focused on measuring diabetes, umbilical artery, middle cerebral artery

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Single living pregnancy.
  • Gestational age: 34-37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
  • Healthy pregnant women in group 1 (control group).
  • History of pregestational DM in group 2 (study group) i.e., patients known to be diabetic before pregnancy whether on diet, oral hypoglycemic drugs or insulin therapy.

Exclusion Criteria:

  • Fetal anomalies.
  • Any 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).

Sites / Locations

  • kasr elainy hospital (Faculty of Medicine - Cairo University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

control group

controlled diabetics

uncontrolled diabetics

Arm Description

60 healthy pregnant women will be included

30 diabetic pregnant women with controlled Diabetes (i.e. HbA1C less than 6.5 %)

30 diabetic pregnant women with uncontrolled Diabetes (i.e. HbA1C equal or more to 6.5 %)

Outcomes

Primary Outcome Measures

the diagnostic value of Umbilical artery Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.
the sensitivity & the specificity of UA RI & PI in predicting the adverse neonatal outcome among diabetic patients.

Secondary Outcome Measures

he diagnostic value of MCA Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.
the sensitivity & the specificity of MCA RI & PI in predicting the adverse neonatal outcome among diabetic patients.

Full Information

First Posted
April 12, 2019
Last Updated
November 7, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03915990
Brief Title
Middle Cerebral and Umbilical Arteries Doppler Indices in the Prediction of Adverse Neonatal Outcome Among Diabetic Pregnant Women
Official Title
Middle Cerebral and Umbilical Arteries Doppler Indices in Pregestational Diabetic Versus Normal Pregnancies and Their Values in Predicting Adverse Neonatal Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
120 patients will be included and divided into two groups; Control group that will include 60 healthy pregnant women and Study group that will include 60 pregestational diabetic pregnant patients which furtherly will be subdivided into two groups according to HbA1C levels namely; controlled diabetics ( will include 30 diabetic pregnant women with controlled DM - HbA1C < 6.5 %) and uncontrolled diabetics (will include 30 diabetic pregnant women with uncontrolled DM - HbA1C ≥ 6.5 %). Umbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient. The recorded neonatal outcomes will include neonatal birth weight, neonatal blood sugar, Apgar score at 1 & 5 min and neonatal intensive care unit admission.
Detailed Description
120 pregnant women (aged from 18- to 40 years old) with singleton healthy living fetus between 34 -37 weeks gestation will be included in the current study and they will be divided into two groups; Control group that will include 60 healthy pregnant women and Study group that will include 60 pregestational diabetic pregnant patients. The latter group will be furtherly subdivided into two groups according to HbA1C levels namely; controlled diabetics (will include 30 diabetic pregnant women with controlled DM - HbA1C < 6.5 %) and uncontrolled diabetics (will include 30 diabetic pregnant women with uncontrolled DM - HbA1C ≥ 6.5 %). The patient will be recruited from the obstetric out-patient clinic and in-patient department (Department of Obstetrics & Gynecology - Kasr El-Aini Hospital - Faculty of Medicine - Cairo University). Diabetic women with either complicated diabetes or any other chronic diseases (e.g., hypertension or renal) will be excluded. Patients with anomalous or IUGR (EFW below the 10th percentile for gestational age) fetuses will be excluded. Patients experienced any pregnancy induced medical disorders, rupture of membranes or oligohydramnios (AFI < the fifth percentile) in the current pregnancy will be also excluded. Informed consent will be obtained from all participants (to share in the study after describing the aim of the study and the potential hazards) then all participants will be subjected to the following: full history taking, complete Physical Examination (general & local), laboratory investigations (Complete blood picture, liver & kidney functions, Fasting and post prandial blood sugar and HbA1C estimation) and routine obstetric ultrasound (to confirm gestational age, assess fetal weight (EFW) and amniotic fluid index (AFI) and to exclude fetal anomalies. Doppler ultrasonography assessment will be done using the apparatus (SonoAce R3 with Doppler unit and convex linear transducer 3.5 MHZ). As regard umbilical artery (UA) Doppler, all patients will be placed in a semi recumbent position with a left lateral tilt, and then the uterine content will be scanned to select an area of amniotic cavity with several loops of cord. Then using a pulsed wave Doppler on a free loop of cord, the characteristic sound and shape of the umbilical artery will be identified. When the screen showed at least 3 consecutive wave forms of similar height, the image will be frozen and umbilical artery Doppler parameters (Resistance index and pulsatility index) will be estimated. A minimum of 3 separate readings will be averaged before the final values are obtained. Umbilical artery Doppler studies will be avoided during fetal activity and fetal breathing because of effect of fetal breathing movements on waveform variability and recording will be performed during fetal apnea. Abnormal UA Doppler velocimetry will be defined if indices more than 95th centile for gestational age or if diastolic flow is either absent or reversed. As regard middle cerebral artery Doppler (MCA), a transverse view of the fetal brain will be obtained at the level of the biparietal diameter. The transducer will then moved towards the base of the skull at the level of the lesser wing of the sphenoid bone. Using color flow imaging, the middle cerebral artery will be seen as a major lateral branch of the circle of Willis, running anterolaterally at the borderline between the anterior and the middle cerebral fossae. The pulsed Doppler sample gate will then placed on the middle portion of this vessel to obtain flow velocity waveforms. When the screen showed at least 3 consecutive wave forms of similar height, the image will be frozen and middle cerebral artery Doppler parameters (Resistance index & pulsatility index) will be estimated. A minimum of 3 separate readings will be averaged before the final values are obtained. Care should be taken to apply minimal pressure to the maternal abdomen with the transducer, as fetal head compression is associated with alterations of intracranial arterial waveforms. Abnormal MCA Doppler velocimetry will be defined if indices less than 5th centile for gestational age. After fetal birth, the following data will be recorded; neonatal birth weight, neonatal blood sugar, Apgar score at 1and 5 min, the need for transfer to neonatal intensive care unit (NICU). Abnormal perinatal outcomes will included one-min and five-min Apgar scores less than 7, hypoglycemia [blood sugar (BS) less than 50 mg/dL], neonatal intensive care unit (NICU) hospitalization. Women with at least one poor outcome will be categorized in the abnormal neonatal outcome group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
diabetes, umbilical artery, middle cerebral artery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
60 healthy pregnant women will be included
Arm Title
controlled diabetics
Arm Type
Active Comparator
Arm Description
30 diabetic pregnant women with controlled Diabetes (i.e. HbA1C less than 6.5 %)
Arm Title
uncontrolled diabetics
Arm Type
Active Comparator
Arm Description
30 diabetic pregnant women with uncontrolled Diabetes (i.e. HbA1C equal or more to 6.5 %)
Intervention Type
Diagnostic Test
Intervention Name(s)
umbilical and middle cerebral artery Doppler
Intervention Description
Umbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient.
Primary Outcome Measure Information:
Title
the diagnostic value of Umbilical artery Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.
Description
the sensitivity & the specificity of UA RI & PI in predicting the adverse neonatal outcome among diabetic patients.
Time Frame
34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)
Secondary Outcome Measure Information:
Title
he diagnostic value of MCA Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.
Description
the sensitivity & the specificity of MCA RI & PI in predicting the adverse neonatal outcome among diabetic patients.
Time Frame
34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Single living pregnancy. Gestational age: 34-37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan). Healthy pregnant women in group 1 (control group). History of pregestational DM in group 2 (study group) i.e., patients known to be diabetic before pregnancy whether on diet, oral hypoglycemic drugs or insulin therapy. Exclusion Criteria: Fetal anomalies. Any 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moutaz El sherbini, MD
Phone
01001588300
Email
mizosherbini@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mahmoud ismail, MSc
Phone
01003457468
Email
dr_mahmoud_ahmed2015@hotmail.com
Facility Information:
Facility Name
kasr elainy hospital (Faculty of Medicine - Cairo University)
City
Cairo
ZIP/Postal Code
115431
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
moutaz el sherbini, MD
Phone
(+2)01001588300
Email
mizosherbini@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Middle Cerebral and Umbilical Arteries Doppler Indices in the Prediction of Adverse Neonatal Outcome Among Diabetic Pregnant Women

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