Prediction of Fetal Macrosomia by US

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 .

Study Overview

• Status: Unknown
• Conditions: Fetal Macrosomia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 102

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Algazeerah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of paticipants who will have babies with macrosomias	To detect number of fetuses who will develop macrosomia	within a week from delivery

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Kasr El Aini Hospital; National Research Centre, Egypt
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Anticipated): May 5, 2019
• Study Completion (Anticipated): June 20, 2019

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Body Weight; Fetal Diseases; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Fetal Macrosomia
• Other Study ID Numbers: macrosomia prediction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: the data that willbe obtained from this research will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No