Effect of Amniotic Fluid Odor on Newborn Adaptation and Stress (AFO-NAS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amniotic Fluid Odor Sterile Distilled Water Odor.
- Who it may be relevant to
- Registry conditions: Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section. Basic parameters: 38 Weeks — 42 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Amniotic Fluid Odor on Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section
Overview
This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Newborns in the intervention group will be exposed to a sterile material moistened with their own amniotic fluid, while newborns in the control group will be exposed to a sterile material moistened with distilled water. Postnatal adaptation, physiological responses, and stress levels will be evaluated at predetermined time points.
Interventions
- Other Amniotic Fluid Odor Sterile Distilled Water Odor
In the intervention group, healthy newborns born by cesarean section will be exposed to the odor of their own amniotic fluid shortly after birth. Amniotic fluid collected during delivery will be applied to a sterile material and positioned near the newborn's nose without direct contact with the skin or airway. The intervention will be administered according to a standardized study protocol. The newborns' postnatal adaptation, physiological parameters, and stress responses will be assessed at pre
Primary outcome measures
- Heart Rate:beats per minute [Time frame: At 30 minutes after birth]
- Respiratory Rate: breaths per minute [Time frame: At 30 minutes after birth]
- Peripheral Oxygen Saturation:percentage [Time frame: At 30 minutes after birth]
- Body Temperature: degrees Celsius [Time frame: At 30 minutes after birth]
Secondary outcome measures (1)
- Neonatal Stress Level [Time frame: 30 minutes after birth]
Eligibility criteria
Inclusion criteria
- Newborns delivered by cesarean section at 38-42 weeks of gestation
- Absence of a maternal history of high-risk pregnancy, including eclampsia, preeclampsia, or gestational diabetes
Exclusion criteria
- Birth weight below 2,500 g
- Birth weight of 4,000 g or above
- Apgar score below 7 at either 1 or 5 minutes after birth
- Presence of a congenital anomaly
- Admission to the neonatal intensive care unit during the early postnatal period
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Aydın Adnan Menderes University — Aydin
Identifiers
NCT: NCT07736235 · ADU-AMNION