CClinicalTrials.gg
Not yet recruitingNCT06917833Updated Apr 9, 2025

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

An observational study in Maternal Obesity and Hypoxia Neonatal, sponsored by Ain Shams University. Not yet recruiting. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
544
Ages
18 Years to 40 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Maternal Obesity
  • Hypoxia Neonatal

Keywords

  • maternal obesity
  • hypoxia neonatal
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

18 - 40 years pregnant females 37 weeks or more

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

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.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
544 participants (estimated)
Patient registry
No

Groups and cohorts

  • group A (case group )

    women with body mass index equal to 25 kg/m2 or more at time of delivery.

    Other: compare infant hypoxic events in both groups

  • group B ( control group )

    women with body mass index (18.5-24.9 kg/m2) at time of delivery

    Other: compare infant hypoxic events in both groups

Interventions

  • Othercompare infant hypoxic events in both groups

    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.

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06917833
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Apr 9, 2025
Start date
Apr 20, 2025 (estimated)
Primary completion
Jan 28, 2026 (estimated)
Completion
Jan 28, 2026 (estimated)
Last update
Apr 9, 2025

Study contacts

Esraa Hussein, master
Contact
esraaghoneimy81@gmail.com
01008057054

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion