Clinical trial NCT06917833: Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
Official title: Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Maternal Obesity
Hypoxia Neonatal
Keywords: maternal obesity
hypoxia neonatal
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 544
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 18 - 40 years pregnant females 37 weeks or more

Brief summary: 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of admission to neonatal observation room
timeFrame: 6 hours post delivery
Secondary outcomes:
measure: Rate of cesarean-sections.
timeFrame: 12 hours
measure: Oxygen saturation at birth.
timeFrame: 2 hours post delivery
measure: Number of babies with NICU Admission.
timeFrame: 6 hours post delivery
measure: Number of babies with birth trauma.
timeFrame: 2 hours post delivery
measure: Number of babies with meconium aspiration.
timeFrame: 2 hours post delivery
Other outcomes:
Locations:
Study officials:
References: