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

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

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:

  1. Age of 18 - 40 years.
  2. Term pregnancy (37 weeks gestation or more)
  3. Singleton pregnancy
  4. Cephalic presentation at time of delivery
  5. In labour

Exclusion Criteria:

  1. Any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders)
  2. Scarred uterus (myomectomy, previous cesarean section)
  3. Macrosomic baby>4 kgs
  4. Condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological CTG, cord prolapse)
  5. Liquor abnormalities (oligohydramnios or polyhydramnios).
  6. Other indications for cesarean sections for example: placenta accreta spectrum
  7. Smokers.
  8. 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.

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

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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