Prediction of Fetal Macrosomia by US

NCT ID: NCT03451838

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-03

Study Completion Date

2019-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fetal Macrosomia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetes mellitus

Pregnant women with diabetes mellitus will be examined by us to measures placental volume and thickness ,IV thickness and HbA1c

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound will be done to every pregnant lady

HbA1c level in blood

Intervention Type DIAGNOSTIC_TEST

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

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound will be done to every pregnant lady

HbA1c level in blood

Intervention Type DIAGNOSTIC_TEST

a blood sample will be taken to measure HbA1c level

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

Ultrasound will be done to every pregnant lady

Intervention Type DIAGNOSTIC_TEST

HbA1c level in blood

a blood sample will be taken to measure HbA1c level

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

National Research Centre, Egypt

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahmoud Alalfy

Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mahmoud Alalfy, M.s.c

Role: PRINCIPAL_INVESTIGATOR

Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Ahmed samy, M.D

Role: STUDY_CHAIR

kasraliny hospital- Aljazeerah hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Algazeerah

Giza, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mahmoud Alalfy, M.s.c

Role: CONTACT

01002611058

Ahmed Elgazzar, M.D

Role: CONTACT

01014005959

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mahmoud Alalfy, master

Role: primary

+201002611058

Ahmed Elgazzar, M.D

Role: backup

+201014005959

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

macrosomia prediction

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Amnioreduction in Polyhydramnios
NCT07067593 NOT_YET_RECRUITING