Obstetric ComplicationNCT04399174
Placental Vasculature for Prediction of Recurrent Fetal Growth Restriction
An observational study of Obstetric Complication, run by Benha University.
Trial summary
: In this Prospective longitudinal observational study, two hundred pregnant women with singleton pregnancy from 11 up to 13 weeks with history of intrauterine growth restriction in a previous pregnancy underwent ultrasound assessment of gestational age , ultrasound assessment of uterine artery pulsatility index… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetric Complication
- What is being tested?
- US
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 15 Jan 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent.
Who may be able to join
- singleton pregnancy from 11 up to 13 weeks.
- History of intrauterine growth restriction in previous pregnancy
Who cannot join
- Smoking women, and
- pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment.
- Ultrasound evidence of congenital anomalies.
About this study
Official title: 3DPD of the Placenta in Fetal Growth Restriction
: In this Prospective longitudinal observational study, two hundred pregnant women with singleton pregnancy from 11 up to 13 weeks with history of intrauterine growth restriction in a previous pregnancy underwent ultrasound assessment of gestational age , ultrasound assessment of uterine artery pulsatility index, placental volume by 3D ultrasound and placental vascularization by 3D power Doppler (3DPD).
Read the detailed description
This Prospective longitudinal observational study was conducted at Benha University hospital starting from December 2016 to May 2019 after approval of faculty Research Ethics Board. Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent. Inclusion criteria: singleton pregnancy from 11 up to 13 weeks. History of intrauterine growth restriction in previous pregnancy Exclusion criteria: Multiple pregnancies, Smoking women, and pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment. Ultrasound evidence of congenital anomalies.
All women underwent ultrasound study which was performed by a member of ultra-sound unit (Volsun 730 pro V; G.E medical system), for assessment of: Gestational age confirmed by crown-rump length assessment, Uterine artery pulsatility index (angle of insonation is<50°, the sampling gate set at 2mm), 3D ultrasound assessment of Placental volume, 3DPD for assessment of placental vascularization. The examination was done with the patient in lithotomy position with slight left lateral tilting to avoid supine hypotension.
After visualization of the placental vasculature, 3D static power Doppler scanning was performed. After scanning the region of interest, placental volume was measured using the VOCAL rotational technique and VOCAL software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA). After completing a full rotation, another analysis was performed using VOCAL Software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA), which automatically calculates placental volume, vascularization index (VI), flow index (FI) and vascularization flow index(VFI). Low dose aspirin 75mg was described for all cases with the beginning of 2nd trimester.
All cases were having a second (between 20 to 24 weeks) and a third ultrasound assessment for exclusion of congenital malformation and assessment of fetal growth parameter and identification of IUGR cases (according to fetal growth curves). (Nicolaides KH et al., 2018). In order to avoid including healthy, yet constitutionally small for gestational age fetuses to the IUGR group, patients' data were included in the study only in cases of IUGR diagnosis confirmed after delivery.
- Conditions
- Obstetric Complication
- Being tested
- US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
placental volume
Assessment of placental volume.
Measured: 11-13 week
vascularization index (VI)
expressed as percentage, measures the number of colour voxels in the studied volume, representing the blood vessels within the tissue
Measured: 11-13 week
uterine doppler
uterine artery pulsatility index
Measured: 11-13 week
flow index (FI)
the average colour value of all colour voxels, representing average colour intensity.
Measured: 11-13 week
vascularization flow index (VFI)
the average colour value of all grey and colour voxels, which represents both blood flow and vascularization
Measured: 11-13 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start15 Dec 2016
- Primary completion20 May 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- More trials run by Benha 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid mohammed salama, Benha University
- Investigators
- khalid salama, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399174
- Sponsor's protocol ID
- khalid8
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
PubMed 11756390
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3DPD of the Placenta in Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT04399174
- Acronym / sponsor ID
- khalid8
- Conditions
- Obstetric Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 22 May 2020 (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.
: In this Prospective longitudinal observational study, two hundred pregnant women with singleton pregnancy from 11 up to 13 weeks with history of intrauterine growth restriction in a previous pregnancy underwent ultrasound assessment of gestational age , ultrasound assessment of uterine artery pulsatility index, placental volume by 3D ultrasound and placental vascularization by 3D power Doppler (3DPD).
Detailed description
This Prospective longitudinal observational study was conducted at Benha University hospital starting from December 2016 to May 2019 after approval of faculty Research Ethics Board. Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent. Inclusion criteria: singleton pregnancy from 11 up to 13 weeks. History of intrauterine growth restriction in previous pregnancy Exclusion criteria: Multiple pregnancies, Smoking women, and pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment. Ultrasound evidence of congenital anomalies.
All women underwent ultrasound study which was performed by a member of ultra-sound unit (Volsun 730 pro V; G.E medical system), for assessment of: Gestational age confirmed by crown-rump length assessment, Uterine artery pulsatility index (angle of insonation is<50°, the sampling gate set at 2mm), 3D ultrasound assessment of Placental volume, 3DPD for assessment of placental vascularization. The examination was done with the patient in lithotomy position with slight left lateral tilting to avoid supine hypotension.
After visualization of the placental vasculature, 3D static power Doppler scanning was performed. After scanning the region of interest, placental volume was measured using the VOCAL rotational technique and VOCAL software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA). After completing a full rotation, another analysis was performed using VOCAL Software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA), which automatically calculates placental volume, vascularization index (VI), flow index (FI) and vascularization flow index(VFI). Low dose aspirin 75mg was described for all cases with the beginning of 2nd trimester.
All cases were having a second (between 20 to 24 weeks) and a third ultrasound assessment for exclusion of congenital malformation and assessment of fetal growth parameter and identification of IUGR cases (according to fetal growth curves). (Nicolaides KH et al., 2018). In order to avoid including healthy, yet constitutionally small for gestational age fetuses to the IUGR group, patients' data were included in the study only in cases of IUGR diagnosis confirmed after delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent.
Key inclusion criteria (2 listed)
- singleton pregnancy from 11 up to 13 weeks.
- History of intrauterine growth restriction in previous pregnancy
Key exclusion criteria (3 listed)
- Smoking women, and
- pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment.
- Ultrasound evidence of congenital anomalies.
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 |
|---|---|---|
| US | Device | – |
Primary outcome
placental volume
Time frame: 11-13 week
Assessment of placental volume.
vascularization index (VI)
Time frame: 11-13 week
expressed as percentage, measures the number of colour voxels in the studied volume, representing the blood vessels within the tissue
uterine doppler
Time frame: 11-13 week
uterine artery pulsatility index
flow index (FI)
Time frame: 11-13 week
the average colour value of all colour voxels, representing average colour intensity.
vascularization flow index (VFI)
Time frame: 11-13 week
the average colour value of all grey and colour voxels, which represents both blood flow and vascularization
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 22 May 2020.
- Results publication: PubMed 11756390Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
- email of the principal investigatorLink provided by the sponsor.
- 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.
khalid salama principal investigator
Benha University
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Complication, run by Benha University.
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 2 inclusion and 3 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
placental volume (time frame: 11-13 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399174, which also lists 1 linked publication.
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 22 May 2020.