- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06917833
Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
April 4, 2025 updated by: Ain Shams University
Offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal BMI.
In terms of Apgar scores at birth, babies of obese mothers have been reported to have a 31% excess risk of having a low Apgar score (defined at <7 at 1 minute) .
Infants born to obese mothers demonstrate a spectrum of outcomes, suggesting that there is a complex interplay of factors that defines the precise altered metabolic environment to which the fetus is exposed and that determines the risk of complications
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators need to improve understanding of the specific molecular factors that contribute either individually or synergistically to detrimental fetal outcomes.
Moreover, The investigators need to identify the essential maternal markers that need to be tightly regulated during pregnancy to improve outcomes.
Here in, The investigators discuss the influence of maternal obesity and factors associated with the obesogenic intrauterine environment on fetal lung development and respiratory outcomes in offspring at birth importantly, The investigators identify a series of molecular changes encountered during pregnancy that may program the observed respiratory outcomes in clinical practice.
The effects of maternal obesity on severe neonatal asphyxia may be partly explained by traumatic labor, which often results from macrosomia.
Another consequence of maternal obesity is fetal hyperinsulinemia, which may be related to chronic hypoxia even without diabetes .
Other mechanisms that explain the effect of maternal obesity on neonatal asphyxia include lipotoxicity, placental inflammation and vasculopathy, and cord coiling.
Evidence has demonstrated altered gene expression in full-term newborns of mothers with obesity, involving dysregulation of brain development, inflammatory and immune signaling, glucose and lipid homeostasis, and oxidative stress
Study Type
Observational
Enrollment (Estimated)
544
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa Hussein, master
- Phone Number: 01008057054
- Email: esraaghoneimy81@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
18 - 40 years pregnant females 37 weeks or more
Description
Inclusion Criteria:
- Age of 18 - 40 years.
- Term pregnancy (37 weeks gestation or more)
- Singleton pregnancy
- Cephalic presentation at time of delivery
- In labour
Exclusion Criteria:
- Any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders)
- Scarred uterus (myomectomy, previous cesarean section)
- Macrosomic baby>4 kgs
- Condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological CTG, cord prolapse)
- Liquor abnormalities (oligohydramnios or polyhydramnios).
- Other indications for cesarean sections for example: placenta accreta spectrum
- Smokers.
- Any abnormalities in follow up of delivery regarding partogram.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group A (case group )
women with body mass index equal to 25 kg/m2 or more at time of delivery.
|
early neonatal resuscitation will be done by the pediatrician according to the guidelines, APGAR score of the baby will be calculated,, any hypoxic events will be traced and any need of respiratory support for the baby or NICU admission, as well as weight of the baby, mode of delivery and any birth traumas will be recorded.all
this will be compared between two groups.
|
|
group B ( control group )
women with body mass index (18.5-24.9
kg/m2) at time of delivery
|
early neonatal resuscitation will be done by the pediatrician according to the guidelines, APGAR score of the baby will be calculated,, any hypoxic events will be traced and any need of respiratory support for the baby or NICU admission, as well as weight of the baby, mode of delivery and any birth traumas will be recorded.all
this will be compared between two groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of admission to neonatal observation room
Time Frame: 6 hours post delivery
|
6 hours post delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of cesarean-sections.
Time Frame: 12 hours
|
12 hours
|
|
Oxygen saturation at birth.
Time Frame: 2 hours post delivery
|
2 hours post delivery
|
|
Number of babies with NICU Admission.
Time Frame: 6 hours post delivery
|
6 hours post delivery
|
|
Number of babies with birth trauma.
Time Frame: 2 hours post delivery
|
2 hours post delivery
|
|
Number of babies with meconium aspiration.
Time Frame: 2 hours post delivery
|
2 hours post delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 20, 2025
Primary Completion (Estimated)
January 28, 2026
Study Completion (Estimated)
January 28, 2026
Study Registration Dates
First Submitted
March 6, 2025
First Submitted That Met QC Criteria
April 4, 2025
First Posted (Actual)
April 9, 2025
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 4, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD344/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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