Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorAin Shams University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of 18 - 40 years.
Term pregnancy (37 weeks gestation or more)
Singleton pregnancy
Cephalic presentation at time of delivery
Disqualifiers
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)
Trial population
18 - 40 years pregnant females 37 weeks or more
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
compare infant hypoxic events in both groups
Other interventionearly 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.
Treatment groups
544 Participants
are divided into 2 treatment groupsGroup A: group A (case group )1 intervention
Group B: group B ( control group )1 intervention
Trial outcomes
Primary outcomes
1
Rate of admission to neonatal observation room
Time frame
6 hours post deliverySecondary outcomes
1
Rate of cesarean-sections.
Time frame
12 hours2
Oxygen saturation at birth.
Time frame
2 hours post delivery3
Number of babies with NICU Admission.
Time frame
6 hours post delivery4
Number of babies with birth trauma.
Time frame
2 hours post deliveryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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