Intrauterine Growth RestrictionNCT06988436
FETAL PULMONARY VEIN AND UMBILICAL ARTERY PULSATILITY INDICES AS PREDICTORS OF FETAL GROWTH RESTRICTION IN DIABETIC AND HYPERTENSIVE PREGNANT WOMEN
An observational study of Intrauterine Growth Restriction, run by Cairo University at 1 site in Egypt.
Trial summary
Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Ultrasound
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 12 May 2025
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care with the following criteria. Women were divided into 2 equal groups (total 82 cases): * Group A: hypertensive group 41 patients. * Group B: diabetic group 41 patients.
Who may be able to join
- Pregnant women between 18 and 44 years.
- Gestational age: 28 - 34 weeks of gestation at time of examination (only women with confirmed GA by sure LMP and/or first trimester US scan).
- Singleton pregnancy.
- Hypertensive women (preexisting or gestational hypertension).
- Diabetic women (preexisting or gestational diabetes).
Who cannot join
- Women with any medical disorder (apart from diabetes and hypertension).
- Women with multiple pregnancies.
- Women with inadequate ultrasound images (i.e., marked obesity).
- Women with fetuses with chromosomal abnormalities or congenital anomalies and other factors that could affect fetal growth.
- Unavailable perinatal outcome data
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study. UAPI and PVPI were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled.
Read the detailed description
Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study. UAPI and PVPI were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled. The umbilical artery Doppler examinations were conducted on a free-floating loop at the middle of the cord, away from its placenta and fetal abdominal insertion sites. The Doppler angle was <60°, for an optimal Doppler signal. The recording was done when fetal breathing movement or uterine contraction was absent. The Doppler wall filter was set at 50 - 100Hz, spectral peak average intensities were below 100 m/wcm2, and pulsed Doppler sample gate size was 2 mm (Adedo et al., 2022). The following umbilical artery Doppler indices (UADI) were calculated automatically by the machine: Peak Systolic Velocity (PSV) in cm/s, End Diastolic Velocity (EDV) in cm/s, Pulsatility Index (PI), Resistive Index (RI), and Systolic/Diastolic Ratio (S/D Ratio). The umbilical artery waveform pattern was also analyzed and classified into: normal diastolic flow, reduced diastolic flow, absent diastolic flow and reversed diastolic flow. The values of UAPI considered abnormal if >95th percentile are as follows: at 28th Wk. > 1.35, 29th Wk. >1.32, 30th Wk. >1.29, 31stWk >1.27, 32ndWk. >1.25, 33thWk >1.22 and 34th Wk >1.2 (Adedo et al., 2022).
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Ultrasound
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL). The machine automatically calculated the estimated fetal weight using the Headlock formula. umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study
| Study group | Role | What they receive |
|---|---|---|
| hypertensive group | Pregnant women diagnosed with preexisting or gestational hypertension Receives: Diagnostic Test: Ultrasound | |
| Diabetic group | Pregnant women diagnosed with preexisting or gestational diabetes Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of fetal growth restriction
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jul 2024
- Primary completion15 Apr 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988436
- Sponsor's protocol ID
- 365
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FETAL PULMONARY VEIN AND UMBILICAL ARTERY PULSATILITY INDICES AS PREDICTORS OF FETAL GROWTH RESTRICTION IN DIABETIC AND HYPERTENSIVE PREGNANT WOMEN
- ClinicalTrials.gov ID
- NCT06988436
- Acronym / sponsor ID
- 365
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 23 May 2025 (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.
Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study. UAPI and PVPI were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled.
Detailed description
Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study. UAPI and PVPI were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled. The umbilical artery Doppler examinations were conducted on a free-floating loop at the middle of the cord, away from its placenta and fetal abdominal insertion sites. The Doppler angle was <60°, for an optimal Doppler signal. The recording was done when fetal breathing movement or uterine contraction was absent. The Doppler wall filter was set at 50 - 100Hz, spectral peak average intensities were below 100 m/wcm2, and pulsed Doppler sample gate size was 2 mm (Adedo et al., 2022). The following umbilical artery Doppler indices (UADI) were calculated automatically by the machine: Peak Systolic Velocity (PSV) in cm/s, End Diastolic Velocity (EDV) in cm/s, Pulsatility Index (PI), Resistive Index (RI), and Systolic/Diastolic Ratio (S/D Ratio). The umbilical artery waveform pattern was also analyzed and classified into: normal diastolic flow, reduced diastolic flow, absent diastolic flow and reversed diastolic flow. The values of UAPI considered abnormal if >95th percentile are as follows: at 28th Wk. > 1.35, 29th Wk. >1.32, 30th Wk. >1.29, 31stWk >1.27, 32ndWk. >1.25, 33thWk >1.22 and 34th Wk >1.2 (Adedo et al., 2022).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive group | – | Diagnostic Test: UltrasoundPregnant women diagnosed with preexisting or gestational hypertension |
| Diabetic group | – | Diagnostic Test: UltrasoundPregnant women diagnosed with preexisting or gestational diabetes |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care with the following criteria. Women were divided into 2 equal groups (total 82 cases): * Group A: hypertensive group 41 patients. * Group B: diabetic group 41 patients.
Key inclusion criteria (5 listed)
- Pregnant women between 18 and 44 years.
- Gestational age: 28 - 34 weeks of gestation at time of examination (only women with confirmed GA by sure LMP and/or first trimester US scan).
- Singleton pregnancy.
- Hypertensive women (preexisting or gestational hypertension).
- Diabetic women (preexisting or gestational diabetes).
Key exclusion criteria (5 listed)
- Women with any medical disorder (apart from diabetes and hypertension).
- Women with multiple pregnancies.
- Women with inadequate ultrasound images (i.e., marked obesity).
- Women with fetuses with chromosomal abnormalities or congenital anomalies and other factors that could affect fetal growth.
- Unavailable perinatal outcome data
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 |
|---|---|---|
| UltrasoundAll the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL). The machine automatically calculated the estimated fetal weight using the Headlock formula. umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study | Diagnostic test | Diabetic group, hypertensive group |
Primary outcome
Prediction of fetal growth restriction
Time frame: At time of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, 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 5 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: finished, as of the sponsor's last update on 23 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of fetal growth restriction (time frame: At time of delivery). 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 May 2025.