PregnancyNCT02473991
Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
An observational study of Pregnancy and Fetal Macrosomia, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of this prospective longitudinal study was to investigate the relationship between placental thickness during the second and third trimesters and placental and birth weights. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Fetal Macrosomia, Intrauterine Growth Restriction
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 395 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: uncomplicated pregnant women who will attend the outpatient clinic at Ain Shams University Maternity Hospital
Who may be able to join
- patient Aged between 18 and 45 years.
- singleton viable pregnancy.
- non scared uterus.
Who cannot join
- systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease)
- known congenital fetal anomalies.
- multiple pregnancy.
- intra uterine fetal death.
- anatomical defect of pregnant uterus
- abnormally located placenta or placental anomalies
Show all 9Show fewer
- morbid obesity
- missing records
- unwilling to incorporate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective longitudinal study was to investigate the relationship between placental thickness during the second and third trimesters and placental and birth weights.
Read the detailed description
The investigator will make certain that the appropriate informed consent process is in place to ensure that potential research subjects, or their authorized representatives, are fully informed about the nature and objectives of the study, the potential risk and benefits of study participation, and their right as research subjects.
All laboratory specimens, evaluation forms, reports, video recordings, and other records that leave the site will not include unique personal data to maintain subject confidentiality.
All patients provided an informed written consent after they were fully instructed about the investigation.The study was approved by ethical committee of Ain Shams University.
All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, parity, body mass index (BMI) and past medical events. Smoking, alcohol and drug use were also determined.
At second and third trimester (15-20 and 30-34 weeks of gestation respectively), the maternal weight, weight gain, BMI, BMI gain and data of ultrasound examination were recorded. At the time of delivery after assessment of maternal weight as mentioned above, the birth weight (in grams), fetal sex, and mode of delivery were taken.
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).
All sonographic examinations were performed trans-abdominal using a Medison X4 ultrasound machine Trans abdominal4.0 megahertz (MHz) probe at The Special Care Center for Fetus Unit at Ain Shams University Maternity Hospital.
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al
Each evaluation was performed by one of two experienced sonographers of our hospital with minimum inter- and intra-observer variability.
After delivery, the placenta was weighed in grams as previously described by Azpurua et al.
Fetal weight (primary objective) and neonatal status and morbidity including baby Apgar scores, fetal distress or fetal death and admission to the neonatal intensive care unit were also determined. All the examinations and data recording were performed by two senior resident physicians.(secondary objective)
- Conditions
- Pregnancy, Fetal Macrosomia, Intrauterine Growth Restriction
- Being tested
- ultrasound
- Medical subject headings
- Fetal Macrosomia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundRadiation
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Weight (Fetal Weight at Birth)
Fetal weight (fetal weight at birth) (in grams)
Measured: 9 months
Placental Thickness in Second Trimester
placental thickness measured in millimeter
Measured: 15-20 weeks of gestation
Placental Thickness at 3rd Trimester
Measured: 30-34 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, amr elsayed elsayed, Ain Shams Maternity Hospital
- Investigators
- AHMED MEKLED, Professor, Study director, Ain Shams UniversityHAYTHAM SABAA, Lecturer, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473991
- Sponsor's protocol ID
- Master degree in Obs & gyn
- Status last verified
- Apr 2017
- First submitted
- 10 May 2015
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, Kliman HJ. Determination of placental weight using two-dimensional sonography and volumetric mathematic modeling. Am J Perinatol. 2010 Feb;27(2):151-5. doi: 10.1055/s-0029-1234034. Epub 2009 Aug 3.
PubMed 19653142Hoddick WK, Mahony BS, Callen PW, Filly RA. Placental thickness. J Ultrasound Med. 1985 Sep;4(9):479-82. doi: 10.7863/jum.1985.4.9.479.
PubMed 3903201
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
- ClinicalTrials.gov ID
- NCT02473991
- Acronym / sponsor ID
- Master degree in Obs & gyn
- Conditions
- Pregnancy, Fetal Macrosomia, Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective longitudinal study was to investigate the relationship between placental thickness during the second and third trimesters and placental and birth weights.
Detailed description
The investigator will make certain that the appropriate informed consent process is in place to ensure that potential research subjects, or their authorized representatives, are fully informed about the nature and objectives of the study, the potential risk and benefits of study participation, and their right as research subjects.
All laboratory specimens, evaluation forms, reports, video recordings, and other records that leave the site will not include unique personal data to maintain subject confidentiality.
All patients provided an informed written consent after they were fully instructed about the investigation.The study was approved by ethical committee of Ain Shams University.
All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, parity, body mass index (BMI) and past medical events. Smoking, alcohol and drug use were also determined.
At second and third trimester (15-20 and 30-34 weeks of gestation respectively), the maternal weight, weight gain, BMI, BMI gain and data of ultrasound examination were recorded. At the time of delivery after assessment of maternal weight as mentioned above, the birth weight (in grams), fetal sex, and mode of delivery were taken.
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).
All sonographic examinations were performed trans-abdominal using a Medison X4 ultrasound machine Trans abdominal4.0 megahertz (MHz) probe at The Special Care Center for Fetus Unit at Ain Shams University Maternity Hospital.
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al
Each evaluation was performed by one of two experienced sonographers of our hospital with minimum inter- and intra-observer variability.
After delivery, the placenta was weighed in grams as previously described by Azpurua et al.
Fetal weight (primary objective) and neonatal status and morbidity including baby Apgar scores, fetal distress or fetal death and admission to the neonatal intensive care unit were also determined. All the examinations and data recording were performed by two senior resident physicians.(secondary objective)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- uncomplicated pregnant women who will attend the outpatient clinic at Ain Shams University Maternity Hospital
Key inclusion criteria (3 listed)
- patient Aged between 18 and 45 years.
- singleton viable pregnancy.
- non scared uterus.
Key exclusion criteria (9 listed)
- systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease)
- known congenital fetal anomalies.
- multiple pregnancy.
- intra uterine fetal death.
- anatomical defect of pregnant uterus
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 |
|---|---|---|
| ultrasoundThe placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion | Radiation | – |
Primary outcome
Fetal Weight (Fetal Weight at Birth)
Time frame: 9 months
Fetal weight (fetal weight at birth) (in grams)
Placental Thickness in Second Trimester
Time frame: 15-20 weeks of gestation
placental thickness measured in millimeter
Placental Thickness at 3rd Trimester
Time frame: 30-34 weeks of pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19653142Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, Kliman HJ. Determination of placental weight using two-dimensional sonography and volumetric mathematic modeling. Am J Perinatol. 2010 Feb;27(2):151-5. doi: 10.1055/s-0029-1234034. Epub 2009 Aug 3.
- Background: PubMed 3903201Hoddick WK, Mahony BS, Callen PW, Filly RA. Placental thickness. J Ultrasound Med. 1985 Sep;4(9):479-82. doi: 10.7863/jum.1985.4.9.479.
- Individual participant dataSharing planned: No
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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 MEKLED, Professor study director
Ain Shams University
HAYTHAM SABAA, Lecturer study director
Ain Shams 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 Pregnancy and Fetal Macrosomia, 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 9 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 2 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fetal Weight (Fetal Weight at Birth) (time frame: 9 months). The study lists 3 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 NCT02473991, which also lists 2 linked publications.
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 2 Aug 2017.