Gestational DiabetesNCT02643225
The Role of Umbilical Cord Thickness in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by Ain Shams University.
Trial summary
The aim of this work is the prediction of fetal macrosomia by measuring: 1. HbA1C. 2. Umbilical cord thickness. 3. Interventricular septum thickness. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Nov 2015
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.
Who may be able to join
- Singleton gestation.
- Gestational age over 27 weeks.
- Intact membranes.
- Normal umbilical morphology (two arteries and one vein).
- Diagnosis of gestational diabetes.
Who cannot join
- The presence of fetal congenital anomalies.
- Multifetal pregnancy.
- Maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.).
- Patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation.
- Patients who used cigarettes or alcohol during pregnancy.
About this study
Official title: The Role of Umbilical Cord Thickness, Interventricular Septum Thickness and HbA1C Levels in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
The aim of this work is the prediction of fetal macrosomia by measuring:
- HbA1C.
- Umbilical cord thickness.
- Interventricular septum thickness.
Read the detailed description
This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.
The following investigation will be performed:
- Calculation of gestational age will be based on the last reliable menstrual period or ultrasound examination within the first trimester. The ultrasound examination will be with Voluson E6 equipped with a 3.5 Hz trans-abdominal probe at fetal medicine unit of maternity hospital Ain Shams University.
- Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively. During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device. The cross sectional area of Wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.
- HbA1c levels will be measured for diabetes patients.
All the patients will be subjected to :
- Full history taking including last menstrual period, medical history and past obstetric history.
- Detailed general physical history examination and obstetrics examination.
- Ultrasound examination in fetal medicine unit maternity hospital Ain shams university.
- Venous blood samples will be taken from patients with gestational diabetes mellitus in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique. The patients will be followed up till delivery. The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with gestational diabetes | case group | |
| non diabetic pregnant women | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)
The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
Measured: at birth
Secondary outcomes (3)
Umbilical Cordcross-sectional Area
the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.
Measured: 36-37 weeks of gestation
Prediction of Fetal Macrosomia by Measuring HbA1C in Participants
Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.
Measured: 36-37 weeks of gestation
Interventricular Septum Thickness
The interventricular septum thickness will be measured by ultrasound examination
Measured: 36-37 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionNov 2015
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.
- Other trials for Gestational DiabetesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643225
- Sponsor's protocol ID
- Diabetes mellitus
- Status last verified
- Jul 2016
- First submitted
- 26 Dec 2015
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Umbilical Cord Thickness, Interventricular Septum Thickness and HbA1C Levels in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02643225
- Acronym / sponsor ID
- Diabetes mellitus
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 18 Aug 2016
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 work is the prediction of fetal macrosomia by measuring:
- HbA1C.
- Umbilical cord thickness.
- Interventricular septum thickness.
Detailed description
This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.
The following investigation will be performed:
- Calculation of gestational age will be based on the last reliable menstrual period or ultrasound examination within the first trimester. The ultrasound examination will be with Voluson E6 equipped with a 3.5 Hz trans-abdominal probe at fetal medicine unit of maternity hospital Ain Shams University.
- Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively. During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device. The cross sectional area of Wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.
- HbA1c levels will be measured for diabetes patients.
All the patients will be subjected to :
- Full history taking including last menstrual period, medical history and past obstetric history.
- Detailed general physical history examination and obstetrics examination.
- Ultrasound examination in fetal medicine unit maternity hospital Ain shams university.
- Venous blood samples will be taken from patients with gestational diabetes mellitus in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique. The patients will be followed up till delivery. The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women with gestational diabetes | – | –case group |
| non diabetic pregnant women | – | –control group |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.
Key inclusion criteria (5 listed)
- Singleton gestation.
- Gestational age over 27 weeks.
- Intact membranes.
- Normal umbilical morphology (two arteries and one vein).
- Diagnosis of gestational diabetes.
Key exclusion criteria (5 listed)
- The presence of fetal congenital anomalies.
- Multifetal pregnancy.
- Maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.).
- Patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation.
- Patients who used cigarettes or alcohol during pregnancy.
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
The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)
Time frame: at birth
The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
3 secondary outcomes
Umbilical Cordcross-sectional Area
Time frame: 36-37 weeks of gestation
Prediction of Fetal Macrosomia by Measuring HbA1C in Participants
Time frame: 36-37 weeks of gestation
Interventricular Septum Thickness
Time frame: 36-37 weeks of gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Ain Shams 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 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 18 Aug 2016. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2016). 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?
The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) (time frame: at birth). 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 18 Aug 2016.