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Prediction of Fetal Macrosomia by US

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03451838
Enrollment
102
Registered
2018-03-02
Start date
2018-03-03
Completion date
2019-06-20
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Macrosomia

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 .

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

Sponsors

Kasr El Aini Hospital
CollaboratorOTHER
National Research Centre, Egypt
CollaboratorOTHER
Aljazeera Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
the number of paticipants who will have babies with macrosomiaswithin a week from deliveryTo detect number of fetuses who will develop macrosomia

Countries

Egypt

Contacts

Primary ContactMahmoud Alalfy, M.s.c
mahmoudalalfy@ymail.com01002611058
Backup ContactAhmed Elgazzar, M.D
elgazzara50@gmail.com01014005959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026