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

NCT07736235 | Recruiting

• 1 other identifier: ADU-AMNION
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section

Outcome Measures

Primary Outcomes (4)

• Heart Rate:beats per minute

  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.

  At 30 minutes after birth

• Respiratory Rate: breaths per minute

  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.

  At 30 minutes after birth

• Peripheral Oxygen Saturation:percentage

  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.

  At 30 minutes after birth

• Body Temperature: degrees Celsius

  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.

  At 30 minutes after birth

Secondary Outcomes (1)

• Neonatal Stress Level

  30 minutes after birth

Study Arms (2)

Amniotic Fluid Odor Group

EXPERIMENTAL

Healthy newborns born by cesarean section in this arm will be exposed to the odor of their own amniotic fluid following birth. Postnatal adaptation and stress responses will be evaluated according to the study protocol.

Other: Amniotic Fluid Odor Sterile Distilled Water Odor

Distilled Water Odor Exposure

PLACEBO COMPARATOR

Healthy newborns born by cesarean section in this arm will be exposed to a sterile material moistened with distilled water following birth. Postnatal adaptation and stress responses will be evaluated according to the study protocol.

Other: Amniotic Fluid Odor Sterile Distilled Water Odor

Interventions

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.

Amniotic Fluid Odor Group; Distilled Water Odor Exposure

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

RECRUITING

Study Officials

• zekiye karaçam, prof

  Aydin Adnan Menderes University

  STUDY CHAIR

Central Study Contacts

funda güler, pHd

CONTACT

+905334888321; fundaguler@adu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, PhD

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: December 16, 2022
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)