Prediction of Fetal Macrosomia by US

• Conditions: Fetal Macrosomia
• Interventions: Diagnostic Test: Ultrasound; Diagnostic Test: HbA1c level in blood

• Registration Number: NCT03451838
• Lead Sponsor: Aljazeera Hospital

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 .

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 Timeline

• Study First Submitted: 2018-02-25
• Study First Submitted QC: 2018-02-25
• Study First Posted: 2018-03-02
• Study Start: 2018-03-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Primary Completion: 2019-05-05
• Study Completion: 2019-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	HbA1c level in blood	Pregnant women with no medical disorders will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c
control group	Ultrasound	Pregnant women with no medical disorders will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c
Diabetes mellitus	Ultrasound	Pregnant women with diabetes mellitus will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c
Diabetes mellitus	HbA1c level in blood	Pregnant women with diabetes mellitus will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c

Primary Outcome Measures

Name	Time	Method
the number of paticipants who will have babies with macrosomias	within a week from delivery	To detect number of fetuses who will develop macrosomia

Trial Locations

Locations (1)

Algazeerah; 🇪🇬 Giza, Egypt