Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Fetal Macrosomia by US

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451838
Recruitment Status : Unknown
Verified January 2019 by Mahmoud Alalfy, Aljazeera Hospital.
Recruitment status was:  Recruiting
First Posted : March 2, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
Kasr El Aini Hospital
National Research Centre, Egypt
Information provided by (Responsible Party):
Mahmoud Alalfy, Aljazeera Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 .

-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 .


Condition or disease Intervention/treatment
Fetal Macrosomia Diagnostic Test: Ultrasound Diagnostic Test: HbA1c level in blood

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus
Actual Study Start Date : March 3, 2018
Estimated Primary Completion Date : May 5, 2019
Estimated Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Diabetes mellitus
Pregnant women with diabetes mellitus will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c
 Diagnostic Test: Ultrasound
Ultrasound will be done to every pregnant lady

Diagnostic Test: HbA1c level in blood
a blood sample will be taken to measure HbA1c level
control group
Pregnant women with no medical disorders will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c
 Diagnostic Test: Ultrasound
Ultrasound will be done to every pregnant lady

Diagnostic Test: HbA1c level in blood
a blood sample will be taken to measure HbA1c level


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein )

Exclusion Criteria:

  1. The presence of fetal congenital anomaly .
  2. Multifetal pregnancy.
  3. Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.)
  4. Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation .
  5. Patient who used cigarette or alcohol during pregnancy.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451838


Contacts
Layout table for location contacts
Contact: Mahmoud Alalfy, M.s.c 01002611058 mahmoudalalfy@ymail.com
Contact: Ahmed Elgazzar, M.D 01014005959 elgazzara50@gmail.com

Locations
Layout table for location information
Egypt
Algazeerah Recruiting
Giza, Egypt
Contact: Mahmoud Alalfy, master    +201002611058    mahmoudalalfy@ymail.com   
Contact: Ahmed Elgazzar, M.D    +201014005959      
Principal Investigator: Mahmoud Alalfy, master         
Sponsors and Collaborators
Aljazeera Hospital
Kasr El Aini Hospital
National Research Centre, Egypt
Investigators
Layout table for investigator information
Principal Investigator: Mahmoud Alalfy, M.s.c Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Study Chair: Ahmed samy, M.D kasraliny hospital- Aljazeerah hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03451838    
Other Study ID Numbers: macrosomia prediction
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the data that willbe obtained from this research will be published

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Macrosomia
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight