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Status unknownNCT03451838Updated Jan 9, 2019

Prediction of Fetal Macrosomia by US

An observational study in Fetal Macrosomia, sponsored by Aljazeera Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Aljazeera Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
18 Years to 43 Years
Sex
Female
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Fetal Macrosomia

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03

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testUltrasound

    Ultrasound will be done to every pregnant lady

  • Diagnostic testHbA1c level in blood

    a blood sample will be taken to measure HbA1c level

05

What researchers measure

Primary outcomes

  1. the number of paticipants who will have babies with macrosomias

    To detect number of fetuses who will develop macrosomia

    Time frame: within a week from delivery

06

Study locations

1 of 1 sites recruiting
  • Algazeerah
    Giza, Egypt
    • Mahmoud Alalfy, master · Contact · mahmoudalalfy@ymail.com · +201002611058
    • Ahmed Elgazzar, M.D · Contact · +201014005959
    • Mahmoud Alalfy, master · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — the data that willbe obtained from this research will be published

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03451838
Lead sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital, National Research Centre, Egypt
Responsible party
Mahmoud Alalfy (Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital) — Principal investigator
First posted
Mar 2, 2018
Start date
Mar 3, 2018
Primary completion
May 5, 2019 (estimated)
Completion
Jun 20, 2019 (estimated)
Last update
Jan 9, 2019

Study contacts

Mahmoud Alalfy, M.s.c
Contact
mahmoudalalfy@ymail.com
01002611058
Ahmed Elgazzar, M.D
Contact
elgazzara50@gmail.com
01014005959
Mahmoud Alalfy, M.s.c
principal investigator · Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Ahmed samy, M.D
study chair · kasraliny hospital- Aljazeerah hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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