PrematurityNCT02401438
Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study
An observational study of Prematurity, run by Ain Shams University at 1 site in Egypt.
Trial summary
5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- 5D ultrasound and 2D ultrasound
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between 28 and 34 weeks scheduled for termination of pregnancy due to medical or obstetric cause
Who may be able to join
- 28 to 34 weeks
- preterm termination of pregnancy
- singleton pregnancy
- any obstetric or medical cause for termination of pregnancy
Who cannot join
- IUFD
- multiple pregnancy
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
Mohammed Laban, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo
Mohammed Laban, MD, laban63@yahoo.com
Alaa Hassanin, MD, 01002554281, alaasayed80@hotmail.com
About this study
5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .
- Conditions
- Prematurity
- Being tested
- 5D ultrasound, 2D ultrasound
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5D ultrasoundOther
2D ultrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with preterm delivery | 5D LB and 2D ultrasounds will be done to pregnant women between 28 and 34 weeks planned for termination of pregnancy for obstetric or medical causes. Receives: Other: 5D ultrasound; Other: 2D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses
Sensitivity specificity positive predictive value and negative predictive values will be determined
Measured: 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2020 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401438
- Sponsor's protocol ID
- m2494
- Status last verified
- Jul 2020
- First submitted
- 19 Mar 2015
- Last updated
- 8 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study
- ClinicalTrials.gov ID
- NCT02401438
- Acronym / sponsor ID
- m2494
- Conditions
- Prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- 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.
5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with preterm delivery | – | Other: 5D ultrasound, Other: 2D ultrasound5D LB and 2D ultrasounds will be done to pregnant women between 28 and 34 weeks planned for termination of pregnancy for obstetric or medical causes. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 28 and 34 weeks scheduled for termination of pregnancy due to medical or obstetric cause
Key inclusion criteria (4 listed)
- 28 to 34 weeks
- preterm termination of pregnancy
- singleton pregnancy
- any obstetric or medical cause for termination of pregnancy
Key exclusion criteria (3 listed)
- IUFD
- multiple pregnancy
- 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 |
|---|---|---|
| 5D ultrasound | Other | pregnant women with preterm delivery |
| 2D ultrasound | Other | pregnant women with preterm delivery |
Primary outcome
Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses
Time frame: 72hours
Sensitivity specificity positive predictive value and negative predictive values will be determined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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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.
Mohammed Laban, MD contact
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 Prematurity, run by Ain Shams 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 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: status not confirmed, as of the sponsor's last update on 8 Jul 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 Mohammed Laban, MD (laban63@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses (time frame: 72hours). 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 8 Jul 2020.