Maternal ObesityNCT06917833
Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
An observational study of Maternal Obesity and Hypoxia Neonatal, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Maternal Obesity, Hypoxia Neonatal
- What is being tested?
- compare infant hypoxic events in both groups
- How many people
- 544 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 28 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 18 - 40 years pregnant females 37 weeks or more
Who may be able to join
- Age of 18 - 40 years.
- Term pregnancy (37 weeks gestation or more)
- Singleton pregnancy
- Cephalic presentation at time of delivery
- In labour
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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
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
- Conditions
- Maternal Obesity, Hypoxia Neonatal
- Being tested
- compare infant hypoxic events in both groups
- Keywords
- maternal obesity, hypoxia neonatal
- Medical subject headings
- Pregnancy in Obesity, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compare infant hypoxic events in both groupsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group A (case group ) | women with body mass index equal to 25 kg/m2 or more at time of delivery. Receives: 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 Receives: Other: compare infant hypoxic events in both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of admission to neonatal observation room
Measured: 6 hours post delivery
Secondary outcomes (5)
Rate of cesarean-sections.
Measured: 12 hours
Oxygen saturation at birth.
Measured: 2 hours post delivery
Number of babies with NICU Admission.
Measured: 6 hours post delivery
Number of babies with birth trauma.
Measured: 2 hours post delivery
Number of babies with meconium aspiration.
Measured: 2 hours post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion28 Jan 2026 (estimated)
- Study completion28 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal ObesityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917833
- Sponsor's protocol ID
- MD344/2024
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT06917833
- Acronym / sponsor ID
- MD344/2024
- Conditions
- Maternal Obesity, Hypoxia Neonatal
- Keywords
- maternal obesity, hypoxia neonatal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 28 Jan 2026 (estimated)
- Study completion
- 28 Jan 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (case group ) | – | Other: compare infant hypoxic events in both groupswomen with body mass index equal to 25 kg/m2 or more at time of delivery. |
| group B ( control group ) | – | Other: compare infant hypoxic events in both groupswomen with body mass index (18.5-24.9 kg/m2) at time of delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 18 - 40 years pregnant females 37 weeks or more
Key inclusion criteria (5 listed)
- Age of 18 - 40 years.
- Term pregnancy (37 weeks gestation or more)
- Singleton pregnancy
- Cephalic presentation at time of delivery
- In labour
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compare infant hypoxic events in both groupsearly 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. | Other | group A (case group ), group B ( control group ) |
Primary outcome
Rate of admission to neonatal observation room
Time frame: 6 hours post delivery
5 secondary outcomes
Rate of cesarean-sections.
Time frame: 12 hours
Oxygen saturation at birth.
Time frame: 2 hours post delivery
Number of babies with NICU Admission.
Time frame: 6 hours post delivery
Number of babies with birth trauma.
Time frame: 2 hours post delivery
Number of babies with meconium aspiration.
Time frame: 2 hours post delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Obesity and Hypoxia Neonatal, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Hussein, master (01008057054, esraaghoneimy81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of admission to neonatal observation room (time frame: 6 hours post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.