NCT06917833

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
544

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

April 9, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

March 6, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

maternal obesityhypoxia neonatal

Outcome Measures

Primary Outcomes (1)

  • Rate of admission to neonatal observation room

    6 hours post delivery

Secondary Outcomes (5)

  • Rate of cesarean-sections.

    12 hours

  • Oxygen saturation at birth.

    2 hours post delivery

  • Number of babies with NICU Admission.

    6 hours post delivery

  • Number of babies with birth trauma.

    2 hours post delivery

  • Number of babies with meconium aspiration.

    2 hours post delivery

Study Arms (2)

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

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 A (case group )group B ( control group )

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

18 - 40 years pregnant females 37 weeks or more

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy in ObesityAsphyxia Neonatorum

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Esraa Hussein, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

April 9, 2025

Study Start

April 20, 2025

Primary Completion

January 28, 2026

Study Completion

January 28, 2026

Last Updated

April 9, 2025

Record last verified: 2025-02