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NCT Number: NCT06917833

Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

compare infant hypoxic events in both groups

Other

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.

Primary outcomes

  1. Rate of admission to neonatal observation room

    Time frame: 6 hours post delivery

Secondary outcomes

  1. Rate of cesarean-sections.

    Time frame: 12 hours

  2. Oxygen saturation at birth.

    Time frame: 2 hours post delivery

  3. Number of babies with NICU Admission.

    Time frame: 6 hours post delivery

  4. Number of babies with birth trauma.

    Time frame: 2 hours post delivery

  5. Number of babies with meconium aspiration.

    Time frame: 2 hours post delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Hussein, master

CONTACT

[email protected]

01008057054

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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