Fetal MacrosomiaNCT03451838
Prediction of Fetal Macrosomia by US
An observational study of Fetal Macrosomia, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type 2 diabetes mellitus . Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Fetal Macrosomia
- What is being tested?
- Ultrasound and HbA1c level in blood
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2018to 20 Jun 2019
- How long will I take part?
- 1 Week
- 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 18 to 43 years
- Women only
- Adult
Study population: Singleton gestational Gestational age over 16-20 weeks with Intact membrane with Normal umbilical morphology (two arteries and one vein ) with DM in one group and no medical disorders in another group
Who may be able to join
- 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein )
Who cannot join
- The presence of fetal congenital anomaly .
- Multifetal pregnancy.
- Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.)
- Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation .
- Patient who used cigarette or alcohol during pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus
Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type 2 diabetes mellitus .
-The delivery of macrosomic infant has potentially severe consequence for both the newborn and mother .Increased birth weight increase the risk in the fetus of shoulder dystocia and premature brachial plexus injury ,and those infant weighing above 4500g are at increased risk for neonatal morbidity ,including the need for assisted ventilation and meconium aspiration .Maternal complication result from operative delivery and include postpartum hemorrhage ,third or fourth degree laceration and postpartum infection .
Read the detailed description
Estimated fetal body weight is needed especially when head measurement is impossible whenever the fetal head is positioned low in pelvic brim .A convenient method for estimating fetal body weight without head measurement was thus required .
-The human placenta develop with the principal function of providing nutrients and oxygen to the fetus ,adequate fetal growth and subsequent normal birth weight depend on normal placenta .
- Conditions
- Fetal Macrosomia
- Being tested
- Ultrasound, HbA1c level in blood
- Medical subject headings
- Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound will be done to every pregnant lady
HbA1c level in bloodDiagnostic test
a blood sample will be taken to measure HbA1c level
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus | Pregnant women with diabetes mellitus will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c Receives: Diagnostic Test: Ultrasound; Diagnostic Test: HbA1c level in blood | |
| control group | Pregnant women with no medical disorders will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c Receives: Diagnostic Test: Ultrasound; Diagnostic Test: HbA1c level in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of paticipants who will have babies with macrosomias
To detect number of fetuses who will develop macrosomia
Measured: within a week from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start3 Mar 2018
- Primary completion5 May 2019 (estimated)
- Study completion20 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MacrosomiaStudies 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
- 102 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, M.s.c, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egyptAhmed samy, M.D, Study chair, kasraliny hospital- Aljazeerah hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451838
- Sponsor's protocol ID
- macrosomia prediction
- Status last verified
- Jan 2019
- First submitted
- 25 Feb 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data that willbe obtained from this research will be published
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03451838
- Acronym / sponsor ID
- macrosomia prediction
- Conditions
- Fetal Macrosomia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 5 May 2019 (estimated)
- Study completion
- 20 Jun 2019 (estimated)
- First posted
- 2 Mar 2018 (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.
Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type 2 diabetes mellitus .
-The delivery of macrosomic infant has potentially severe consequence for both the newborn and mother .Increased birth weight increase the risk in the fetus of shoulder dystocia and premature brachial plexus injury ,and those infant weighing above 4500g are at increased risk for neonatal morbidity ,including the need for assisted ventilation and meconium aspiration .Maternal complication result from operative delivery and include postpartum hemorrhage ,third or fourth degree laceration and postpartum infection .
Detailed description
Estimated fetal body weight is needed especially when head measurement is impossible whenever the fetal head is positioned low in pelvic brim .A convenient method for estimating fetal body weight without head measurement was thus required .
-The human placenta develop with the principal function of providing nutrients and oxygen to the fetus ,adequate fetal growth and subsequent normal birth weight depend on normal placenta .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus | – | Diagnostic Test: Ultrasound, Diagnostic Test: HbA1c level in bloodPregnant women with diabetes mellitus will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c |
| control group | – | Diagnostic Test: Ultrasound, Diagnostic Test: HbA1c level in bloodPregnant women with no medical disorders will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Singleton gestational Gestational age over 16-20 weeks with Intact membrane with Normal umbilical morphology (two arteries and one vein ) with DM in one group and no medical disorders in another group
Key inclusion criteria (1 listed)
- 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein )
Key exclusion criteria (5 listed)
- The presence of fetal congenital anomaly .
- Multifetal pregnancy.
- Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.)
- Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation .
- Patient who used cigarette 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound will be done to every pregnant lady | Diagnostic test | Diabetes mellitus, control group |
| HbA1c level in blooda blood sample will be taken to measure HbA1c level | Diagnostic test | Diabetes mellitus, control group |
Primary outcome
the number of paticipants who will have babies with macrosomias
Time frame: within a week from delivery
To detect number of fetuses who will develop macrosomia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No. the data that willbe obtained from this research will be published
Related trials for Fetal Macrosomia
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Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
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Not yet recruitingObservational study
Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness
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New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
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Enrolling by invitation
Artificial Intelligence and Gestacional Diabetes
Gestational Diabetes, Macrosomia, Fetal
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.
Mahmoud Alalfy, M.s.c principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Ahmed samy, M.D study chair
kasraliny hospital- Aljazeerah hospital
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 Fetal Macrosomia, run by Aljazeera 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 1 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 9 Jan 2019. 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 Mahmoud Alalfy, M.s.c (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of paticipants who will have babies with macrosomias (time frame: within a week from delivery). 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 9 Jan 2019.