Ireland
--:--IST
Recruiting Not applicable

Effect of Amniotic Fluid Odor on Newborn Adaptation and Stress (AFO-NAS)

NCT07736235 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2022-12-16
Last updated
2026-07-30

Condition(s) studied

Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section

Investigational drug(s) / intervention(s)

Amniotic Fluid Odor Sterile Distilled Water Odor

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 predetermined time points.

Study summary

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.

Eligibility

Sex
ALL
Min age
38 Weeks
Max age
42 Weeks
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Heart Rate:beats per minute — At 30 minutes after birth
    The newborn's heart rate will be measured using a pulse oximeter and recorded as beats per minute. Heart rate values will be compared between the amniotic fluid odor group and the sterile distilled water odor group.
  • Respiratory Rate: breaths per minute — At 30 minutes after birth
    The newborn's respiratory rate will be assessed by counting respiratory movements for one minute and recorded as breaths per minute. Respiratory rate values will be compared between the study groups.
  • Peripheral Oxygen Saturation:percentage — At 30 minutes after birth
    The newborn's peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. Oxygen saturation values will be compared between the study groups.
  • Body Temperature: degrees Celsius — At 30 minutes after birth
    The newborn's body temperature will be measured using a digital thermometer and recorded in degrees Celsius. Body temperature values will be compared between the study groups.

Trial sites (1)

FacilityCityRegionStatus
Aydın Adnan Menderes University Aydin Efeler Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07736235 on ClinicalTrials.gov ↗ ← All trials in Turkey