Prediction of Fetal Macrosomia by US

NCT03451838 | Unknown DMC

• 1 other identifier: macrosomia prediction
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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 .

Conditions

Fetal Macrosomia

Outcome Measures

Primary Outcomes (1)

• the number of paticipants who will have babies with macrosomias

  To detect number of fetuses who will develop macrosomia

  within a week from delivery

Study Arms (2)

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; 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

Diagnostic Test: Ultrasound; Diagnostic Test: HbA1c level in blood

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasound will be done to every pregnant lady

Diabetes mellitus; control group

HbA1c level in blood DIAGNOSTIC_TEST

a blood sample will be taken to measure HbA1c level

Diabetes mellitus; control group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: pregnant females
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aljazeera Hospital: lead
• Kasr El Aini Hospital: collaborator
• National Research Centre, Egypt: collaborator

Study Sites (1)

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Fetal Macrosomia

Interventions

Ultrasonography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mahmoud Alalfy, M.s.c

  Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

  PRINCIPAL INVESTIGATOR

• Ahmed samy, M.D

  kasraliny hospital- Aljazeerah hospital

  STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy, M.s.c

CONTACT

01002611058; mahmoudalalfy@ymail.com

Ahmed Elgazzar, M.D

CONTACT

01014005959; elgazzara50@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: March 3, 2018
• Primary Completion: May 5, 2019
• Study Completion: June 20, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)