Intrauterine Growth RestrictionNCT01501851
Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness
An observational study of Intrauterine Growth Restriction, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and Thickness Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction
- How many people
- 265 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2010to May 2012
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: tertiarty care clinic
Who may be able to join
- Singleton viable pregnancy.
- Gestational age at least 36 complete weeks as calculated by LMP.
- Non scared uterus.
Who cannot join
- Multiple fetal pregnancy.
- Intrauterine fetal death.
- Known congenital fetal anomalies.
- Presence of uterine or adnexal gross pathology.
- Presence of any medical disorder e.g. Diabetes mellitus \& hypertension.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
outpatient clinic at Ain Shams University Maternity Hospital.
Cairo, Cairo Governorate
adel shafik, 02201005223586, shafikadel@hotmail.com
About this study
Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and Thickness
Read the detailed description
The aim of the present study is to assess the value of using ultrasound measurement of placental diameter and thickness as a predictor of low birthweight.
- Conditions
- Intrauterine Growth Restriction
- Medical subject headings
- Fetal Growth Retardation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
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.
- 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
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osama ismail kamel ibrahim, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501851
- Sponsor's protocol ID
- placenta and lowbirth weight
- Status last verified
- Dec 2011
- First submitted
- 26 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness
- ClinicalTrials.gov ID
- NCT01501851
- Acronym / sponsor ID
- placenta and lowbirth weight
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 29 Dec 2011 (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.
Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and Thickness
Detailed description
The aim of the present study is to assess the value of using ultrasound measurement of placental diameter and thickness as a predictor of low birthweight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- tertiarty care clinic
Key inclusion criteria (3 listed)
- Singleton viable pregnancy.
- Gestational age at least 36 complete weeks as calculated by LMP.
- Non scared uterus.
Key exclusion criteria (5 listed)
- Multiple fetal pregnancy.
- Intrauterine fetal death.
- Known congenital fetal anomalies.
- Presence of uterine or adnexal gross pathology.
- Presence of any medical disorder e.g. Diabetes mellitus \& hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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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.
outpatient clinic at Ain Shams University Maternity Hospital.
Cairo, Egypt
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 Ain Shams Maternity Hospital 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 3 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 29 Dec 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 29 Dec 2011.