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NCT Number: NCT07736235

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

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.

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Key information

Conditions

Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section

Age range

38 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotic Fluid Odor Sterile Distilled Water Odor

Other

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.

Primary outcomes

  1. Heart Rate:beats per minute

    Time frame: 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.

  2. Respiratory Rate: breaths per minute

    Time frame: 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.

  3. Peripheral Oxygen Saturation:percentage

    Time frame: 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.

  4. Body Temperature: degrees Celsius

    Time frame: 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.

Secondary outcomes

  1. Neonatal Stress Level

    Time frame: 30 minutes after birth

    Neonatal stress will be assessed using the Neonatal Stress Scale developed by Ceylan and Bolışık. The scale consists of eight subgroups: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. Each subgroup is scored from 0 to 2, resulting in a total score ranging from 0 to 16. A score of 0 indicates no stress, and higher scores indicate a higher level of neonatal stress and therefore a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

funda güler, pHd

CONTACT

[email protected]

+905334888321

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effect of Amniotic Fluid Odor on Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section

Acronym: AFO-NAS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.