Prediction of Fetal Macrosomia by US

Sponsor
Aljazeera Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03451838
Collaborator
Kasr El Aini Hospital (Other), National Research Centre, Egypt (Other)
102
1
15.6
6.5

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
102 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus
Actual Study Start Date :
Mar 3, 2018
Anticipated Primary Completion Date :
May 5, 2019
Anticipated Study Completion Date :
Jun 20, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. the number of paticipants who will have babies with macrosomias [within a week from delivery]

    To detect number of fetuses who will develop macrosomia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 43 Years
Sexes Eligible for Study:
Female
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

Locations

Site City State Country Postal Code
1 Algazeerah Giza Egypt

Sponsors and Collaborators

  • Aljazeera Hospital
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Mar 2, 2018
Last Update Posted:
Jan 9, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2019