Gestational DiabetesNCT05410080
the Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome
An observational study of Gestational Diabetes and Pre-Gestational Diabetes, run by Cairo University at 2 sites in Egypt.
Trial summary
To determine and evaluate the diagnostic performance of Doppler sonography of umbilical artery (UA), fetal middle cereberal artery (MCA), ductus venosus (VD) and umbilical vein (UV) for prediction of adverse perinatal outcome among diabetic pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes, Pre-Gestational Diabetes, IUGR
- What is being tested?
- Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study
- How many people
- 140 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jun 2022to 20 Oct 2022
- Phase
- Observational
- 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 35 years
- Women only
- Adult
Study population: 140 pregnant women, will be recruited from emergency and inpatients departments.
Who may be able to join
- The included women age will range between 18 and 35 years old.
- They will carry a singleton healthy living fetus at a gestational age between 34 and 39 weeks (confirmed by a reliable date for the last menstrual period or/and 1st trimester ultrasound scan).
- known to be diabetic in the current pregnancy (PGDM or GDM).
Who cannot join
- Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes were excluded from the study.
- women with pre-labour rupture of membrane.
- antepartum hemorrhage, fetuses with congenital anomalies .
- who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University
Cairo, 02
Hany Saad, MD, 01001817211, hanysaad25280@gmail.com
Hadeer Meshaal, MD, 01001435238, dr_hadeer@live.com
- Recruiting
Kasr Alainy hospital (Faculty of Medicine-Cairo University)
Cairo, 11956
Kasr Alainy
About this study
Official title: the Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome Among Diabetic Pregnant Patients
To determine and evaluate the diagnostic performance of Doppler sonography of umbilical artery (UA), fetal middle cereberal artery (MCA), ductus venosus (VD) and umbilical vein (UV) for prediction of adverse perinatal outcome among diabetic pregnant women.
Read the detailed description
The included women age will range between 18 and 35 years old. They will be pregnant in a singleton healthy living fetus at a gestational age between 34 and 39 weeks (confirmed by a reliable date for the last menstrual period or/and 1st trimester ultrasound scan). Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes will be excluded from the study. Exclusion criteria also include women with pre-labour rupture of membrane, antepartum hemorrhage, fetuses with congenital anomalies and those who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery. According to NICE guidelines 2015[13], gestational diabetes is diagnosed if the woman has either:
- A fasting plasma glucose level of 5.6 mmol/litre (100 mg/dL) or above Or
- A 2-hour plasma glucose level of 7.8 mmol/litre (140 mg/dL) or above. Informed written consents will be obtained from all participants after explanation of the study and its aims. All participants be subjected to the following: Full history taking [including a detailed history of the diabetes state during the current pregnancy [e.g., onset, course, duration, type, current medications and whether the blood sugar level is controlled or not ], complete physical examination including general [ BMI \& blood pressure measurement] and obstetric examinations, laboratory investigations [Complete blood count - fasting blood sugar,2 hours postprandial \& HBA1C - liver enzymes \& kidney function-urine analysis for glucosuria and ketonuria] and obstetric ultrasound [to confirm fetal viability \& number, to assess gestational age, estimated fetal weight, and growth percentile and to measure amniotic fluid index] and fetal Doppler ultrasonography assessment using GE Voluson Pro-V and GE Voluson E10 (GE Healthcare, Milwaukee, WI, USA) ultrasonography system with 3.5-5 MHz abdominal transducer. The color flow imaging (to identify the vessels) \& pulsed wave velocimetry will be used to obtain flow velocity waveforms within 24 hours of pregnancy termination. In all Doppler studies, while the woman is lying in a semi-recumbent position, the angle of insonation of the vessels is less than 45 degrees; the high-pass filter is set at 100 Hz. Care is taken not to exert undue pressure on the fetal head because this alters the flow velocity waveforms from the MCA. Furthermore, examination of the fetal vessels will be performed in the absence of fetal body and respiratory movements, with a fetal heart rate ranging from 120-160 beats per minute. Measurements will be obtained from ≥ 4 consecutive flow velocity waveforms of good quality and averaged. Umbilical artery (UA) Doppler will be evaluated from a free- floating loop in the mid portion of the cord. Middle cerebral artery (MCA) Doppler will be obtained from a transverse image of the fetal head at the level of sphenoid bones.
Colour flow imaging will be used to display the circle of Willis. Then, calculation of the cerebro-placental ratio (CPR) will be done. Ductus venosus (DV) Doppler will be sampled soon after its origin from the umbilical vein. Also measurement of fetal umbilical vein (UV) flow will be done.
From the flow velocity waveforms of the UA and MCA, the pulsatility index (PI) \& the resistance index (RI) will be measured. From the flow velocity waveforms of the DV, peak velocity index (PVIV), peak systolic velocity (PSV) and A wave will be measured.
From the umbilical vein flow, the presence or absence of pulsatile flow will be recorded.
All labours will be attended by an expert neonatologist who will be blinded to the results of Doppler indices measurements \& the following will be recorded: APGAR score at (1 \& 5 min) -Neonatal birth weight - Fetal growth restriction (FGR) will be defined as birth weight of less than 10 th percentile of newborn weight in normal pregnancies at corresponding gestational age - Fetal macrosomia will be defined as birth weight of more than 90th percentile of newborn weight in normal pregnancies at corresponding gestational age - The occurrence of respiratory complications [Transient Tachypnea of the newborn (TTN) or Respiratory Distress Syndrome (RDS)] - The occurrence of neonatal hypoglycemia was defined as blood glucose level less than 2 mmol/liter (35 mg/dL) - The further need for neonatal intensive care unit (NICU) admission and Perinatal death.
- Being tested
- Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study
- Medical subject headings
- Diabetes, Gestational, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler studyDiagnostic test
Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study
| Study group | Role | What they receive |
|---|---|---|
| good perinatal outcome | Fasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler Receives: Diagnostic Test: Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study | |
| poor perinatal outcome | Fasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler Receives: Diagnostic Test: Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic value of umbilical artery (UA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients
The diagnostic value of umbilical artery (UA) Doppler indices (RI \& PI) in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of umbilical artery RI \& PI in detecting adverse perinatal outcome.
Measured: within 24 hours before delivery
The diagnostic value of middle cerebral artery (MCA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients
The diagnostic value of middle cerebral artery (MCA) Doppler indices (RI \& PI) in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of middle cerebral artery RI \& PI in detecting adverse perinatal outcome.
Measured: within 24 hours before delivery
Secondary outcomes (2)
The diagnostic value of cerebroplacental ratio (CPR) in predicting adverse perinatal outcome among diabetic pregnant patients.
The diagnostic value of cerebroplacental ratio (CPR) [MCA/UA PI] in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of CPR in detecting adverse perinatal outcome.
Measured: within 24 hours before delivery
The diagnostic value of ductus venosus Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients.
The diagnostic value of ductus venosus Doppler indices ( PVIV,PSV and abnormal A wave) in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of ductus venosus PVIV,PSV and abnormal A wave in detecting adverse perinatal outcome.
Measured: within 24 hours before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Jun 2022
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany saad, Cairo University
- Investigators
- Hany Saad, MD, Principal investigator, Kasr Alainy Hospital(Faculty of Medicine -Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410080
- Sponsor's protocol ID
- Hany Saad
- Status last verified
- Aug 2022
- First submitted
- 6 May 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome Among Diabetic Pregnant Patients
- ClinicalTrials.gov ID
- NCT05410080
- Acronym / sponsor ID
- Hany Saad
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 8 Jun 2022 (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.
To determine and evaluate the diagnostic performance of Doppler sonography of umbilical artery (UA), fetal middle cereberal artery (MCA), ductus venosus (VD) and umbilical vein (UV) for prediction of adverse perinatal outcome among diabetic pregnant women.
Detailed description
The included women age will range between 18 and 35 years old. They will be pregnant in a singleton healthy living fetus at a gestational age between 34 and 39 weeks (confirmed by a reliable date for the last menstrual period or/and 1st trimester ultrasound scan). Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes will be excluded from the study. Exclusion criteria also include women with pre-labour rupture of membrane, antepartum hemorrhage, fetuses with congenital anomalies and those who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery. According to NICE guidelines 2015[13], gestational diabetes is diagnosed if the woman has either:
- A fasting plasma glucose level of 5.6 mmol/litre (100 mg/dL) or above Or
- A 2-hour plasma glucose level of 7.8 mmol/litre (140 mg/dL) or above. Informed written consents will be obtained from all participants after explanation of the study and its aims. All participants be subjected to the following: Full history taking [including a detailed history of the diabetes state during the current pregnancy [e.g., onset, course, duration, type, current medications and whether the blood sugar level is controlled or not ], complete physical examination including general [ BMI \& blood pressure measurement] and obstetric examinations, laboratory investigations [Complete blood count - fasting blood sugar,2 hours postprandial \& HBA1C - liver enzymes \& kidney function-urine analysis for glucosuria and ketonuria] and obstetric ultrasound [to confirm fetal viability \& number, to assess gestational age, estimated fetal weight, and growth percentile and to measure amniotic fluid index] and fetal Doppler ultrasonography assessment using GE Voluson Pro-V and GE Voluson E10 (GE Healthcare, Milwaukee, WI, USA) ultrasonography system with 3.5-5 MHz abdominal transducer. The color flow imaging (to identify the vessels) \& pulsed wave velocimetry will be used to obtain flow velocity waveforms within 24 hours of pregnancy termination. In all Doppler studies, while the woman is lying in a semi-recumbent position, the angle of insonation of the vessels is less than 45 degrees; the high-pass filter is set at 100 Hz. Care is taken not to exert undue pressure on the fetal head because this alters the flow velocity waveforms from the MCA. Furthermore, examination of the fetal vessels will be performed in the absence of fetal body and respiratory movements, with a fetal heart rate ranging from 120-160 beats per minute. Measurements will be obtained from ≥ 4 consecutive flow velocity waveforms of good quality and averaged. Umbilical artery (UA) Doppler will be evaluated from a free- floating loop in the mid portion of the cord. Middle cerebral artery (MCA) Doppler will be obtained from a transverse image of the fetal head at the level of sphenoid bones.
Colour flow imaging will be used to display the circle of Willis. Then, calculation of the cerebro-placental ratio (CPR) will be done. Ductus venosus (DV) Doppler will be sampled soon after its origin from the umbilical vein. Also measurement of fetal umbilical vein (UV) flow will be done.
From the flow velocity waveforms of the UA and MCA, the pulsatility index (PI) \& the resistance index (RI) will be measured. From the flow velocity waveforms of the DV, peak velocity index (PVIV), peak systolic velocity (PSV) and A wave will be measured.
From the umbilical vein flow, the presence or absence of pulsatile flow will be recorded.
All labours will be attended by an expert neonatologist who will be blinded to the results of Doppler indices measurements \& the following will be recorded: APGAR score at (1 \& 5 min) -Neonatal birth weight - Fetal growth restriction (FGR) will be defined as birth weight of less than 10 th percentile of newborn weight in normal pregnancies at corresponding gestational age - Fetal macrosomia will be defined as birth weight of more than 90th percentile of newborn weight in normal pregnancies at corresponding gestational age - The occurrence of respiratory complications [Transient Tachypnea of the newborn (TTN) or Respiratory Distress Syndrome (RDS)] - The occurrence of neonatal hypoglycemia was defined as blood glucose level less than 2 mmol/liter (35 mg/dL) - The further need for neonatal intensive care unit (NICU) admission and Perinatal death.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good perinatal outcome | – | Diagnostic Test: Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler studyFasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler |
| poor perinatal outcome | – | Diagnostic Test: Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler studyFasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 140 pregnant women, will be recruited from emergency and inpatients departments.
Key inclusion criteria (3 listed)
- The included women age will range between 18 and 35 years old.
- They will carry a singleton healthy living fetus at a gestational age between 34 and 39 weeks (confirmed by a reliable date for the last menstrual period or/and 1st trimester ultrasound scan).
- known to be diabetic in the current pregnancy (PGDM or GDM).
Key exclusion criteria (4 listed)
- Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes were excluded from the study.
- women with pre-labour rupture of membrane.
- antepartum hemorrhage, fetuses with congenital anomalies .
- who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery.
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 |
|---|---|---|
| Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler studyFasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study | Diagnostic test | good perinatal outcome, poor perinatal outcome |
Primary outcome
The diagnostic value of umbilical artery (UA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients
Time frame: within 24 hours before delivery
The diagnostic value of umbilical artery (UA) Doppler indices (RI \& PI) in predicting adverse perinatal outcome among diabetic pregnant patients. Sensitivity and specificity of umbilical artery RI \& PI in detecting adverse perinatal outcome.
The diagnostic value of middle cerebral artery (MCA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients
Time frame: within 24 hours before delivery
The diagnostic value of middle cerebral artery (MCA) Doppler indices (RI \& PI) in predicting adverse perinatal outcome among diabetic pregnant patients. Sensitivity and specificity of middle cerebral artery RI \& PI in detecting adverse perinatal outcome.
2 secondary outcomes
The diagnostic value of cerebroplacental ratio (CPR) in predicting adverse perinatal outcome among diabetic pregnant patients.
Time frame: within 24 hours before delivery
The diagnostic value of ductus venosus Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients.
Time frame: within 24 hours before delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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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.
Hany Saad, MD principal investigator
Kasr Alainy Hospital(Faculty of Medicine -Cairo university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Pre-Gestational Diabetes, run by Cairo University at 2 sites 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 3 inclusion and 4 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Hany Saad, MD (01001817211, hanysaad25280@gmail.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 (UA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients (time frame: within 24 hours before delivery). The study lists 2 primary outcomes in all. 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 23 Aug 2022.