Diabetes Mellitus, Type 1NCT03915990
Middle Cerebral and Umbilical Arteries Doppler Indices in the Prediction of Adverse Neonatal Outcome Among Diabetic Pregnant Women
A study testing umbilical and middle cerebral artery Doppler in people with Diabetes Mellitus, Type 1, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- umbilical and middle cerebral artery Doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
kasr elainy hospital (Faculty of Medicine - Cairo University)
Cairo, 115431
moutaz el sherbini, MD, (+2)01001588300, mizosherbini@yahoo.com
About this study
Official title: Middle Cerebral and Umbilical Arteries Doppler Indices in Pregestational Diabetic Versus Normal Pregnancies and Their Values in Predicting Adverse Neonatal Outcome
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- umbilical and middle cerebral artery Doppler
- Keywords
- diabetes, umbilical artery, middle cerebral artery
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical and middle cerebral artery DopplerDiagnostic test
Umbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | 60 healthy pregnant women will be included Receives: Diagnostic Test: umbilical and middle cerebral artery Doppler |
| controlled diabetics | Active comparator | 30 diabetic pregnant women with controlled Diabetes (i.e. HbA1C less than 6.5 %) Receives: Diagnostic Test: umbilical and middle cerebral artery Doppler |
| uncontrolled diabetics | Active comparator | 30 diabetic pregnant women with uncontrolled Diabetes (i.e. HbA1C equal or more to 6.5 %) Receives: Diagnostic Test: umbilical and middle cerebral artery Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)
Secondary outcomes (1)
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.
Measured: 34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jul 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moutaz Sherbini, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915990
- Sponsor's protocol ID
- 35343332
- Status last verified
- Nov 2020
- First submitted
- 12 Apr 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Cerebral and Umbilical Arteries Doppler Indices in Pregestational Diabetic Versus Normal Pregnancies and Their Values in Predicting Adverse Neonatal Outcome
- ClinicalTrials.gov ID
- NCT03915990
- Acronym / sponsor ID
- 35343332
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes, umbilical artery, middle cerebral artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Diagnostic Test: umbilical and middle cerebral artery Doppler60 healthy pregnant women will be included |
| controlled diabetics | Active comparator | Diagnostic Test: umbilical and middle cerebral artery Doppler30 diabetic pregnant women with controlled Diabetes (i.e. HbA1C less than 6.5 %) |
| uncontrolled diabetics | Active comparator | Diagnostic Test: umbilical and middle cerebral artery Doppler30 diabetic pregnant women with uncontrolled Diabetes (i.e. HbA1C equal or more to 6.5 %) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| umbilical and middle cerebral artery DopplerUmbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient. | Diagnostic test | control group, controlled diabetics, uncontrolled diabetics |
Primary outcome
the diagnostic value of Umbilical artery Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.
Time frame: 34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)
the sensitivity \& the specificity of UA RI \& PI in predicting the adverse neonatal outcome among diabetic patients.
1 secondary outcome
he diagnostic value of MCA Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.
Time frame: 34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical and middle cerebral artery Doppler in people with Diabetes Mellitus, Type 1, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moutaz El sherbini, MD (01001588300, mizosherbini@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic value of Umbilical artery Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients. (time frame: 34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.