Prediction of Fetal Macrosomia by US

Fetal Macrosomia Clinical Trial

Official title:

The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03451838
• Other study ID #: macrosomia prediction
• Status: Recruiting
• Start date: March 3, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: January 2019
• Source: Aljazeera Hospital
• Contact: Mahmoud Alalfy, M.s.c
• Phone: 01002611058
• Email: mahmoudalalfy[@]ymail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 .

-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 .

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: June 20, 2019
• Est. primary completion date: May 5, 2019
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Macrosomia

Intervention

Diagnostic Test:
• Ultrasound
Ultrasound will be done to every pregnant lady
• HbA1c level in blood
a blood sample will be taken to measure HbA1c level

Locations

Country	Name	City	State
Egypt	Algazeerah	Giza

Sponsors (3)

Lead Sponsor	Collaborator
Aljazeera Hospital	Kasr El Aini Hospital, National Research Center, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of paticipants who will have babies with macrosomias	To detect number of fetuses who will develop macrosomia	within a week from delivery