NCT07719751

Brief Summary

During intrauterine life, the fetus is connected to the mother via the placenta; with birth, the extrauterine adaptation process begins. The first six hours after birth are defined as the "adaptation period" for the newborn and consist of three stages. In this process, the first reactive period is particularly critical because the initial assessments determine the newborn's well-being. All organs, especially the respiratory and cardiovascular systems, are rapidly activated, and adaptation parameters are monitored. Evidence-based care interventions applied by midwives during this period directly affect the newborn's physiological stability and long-term health. The timing of umbilical cord clamping is a decisive factor in this adaptation. The World Health Organization recommends waiting at least 1 minute after birth for term and stable preterm infants, ideally with a delay of 1-3 minutes for clamping. Blood flow from the placenta to the baby continues for the first few minutes after birth. Therefore, not clamping the umbilical cord until 2-3 minutes have passed or until the cord pulse has completely stopped provides a physiological blood transfer. In this process, defined as "placental transfusion," a large portion of the blood passes to the baby within the first 3 minutes, contributing to an increase in circulatory volume and hemoglobin levels. In premature infants, stem cell transfer reduces complications and provides long-term benefits. In addition, this practice increases venous return, supporting heart filling and facilitating cardiorespiratory transition. In infants who undergo delayed clamping, oxygen saturation rises faster and irregular heartbeats are less common.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2026Nov 2026

Study Start

First participant enrolled

April 11, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2026

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

May 8, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

NewbornProneLeft side lyingPositionComfort

Outcome Measures

Primary Outcomes (1)

  • Heart rate (pulse)

    Heart rate will be measured using a pulse oximeter during delayed umbilical cord clamping while the newborn is positioned either in the prone or left lateral position.

    During delayed umbilical cord clamping (within the first minutes after birth)

Secondary Outcomes (1)

  • Oxygen saturation (SpO₂)

    During delayed umbilical cord clamping (within the first minutes after birth)

Other Outcomes (3)

  • Respiratory pattern

    During delayed umbilical cord clamping (within the first minutes after birth)

  • Skin color

    During delayed umbilical cord clamping (within the first minutes after birth)

  • Newborn Comfort Behavior Scale score

    During delayed umbilical cord clamping (within the first minutes after birth)

Study Arms (2)

Prone position group

EXPERIMENTAL

Newborns should be placed in a prone position immediately after birth.

Other: Prone position

Left Side Lying Position Group

EXPERIMENTAL

Newborns should be placed on their left side immediately after birth.

Other: Left side lying position

Interventions

After birth, the newborn will be positioned vertically on the linea line above the mother's mons pubis and monitored while lying prone.

Prone position group

After birth, the newborn will be positioned vertically on the linea line above the mother's mons pubis and monitored while lying left side.

Left Side Lying Position Group

Eligibility Criteria

Age0 Minutes+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The newborn must have been born at term (≥37 weeks)
  • Born from a singleton pregnancy
  • Born vaginally
  • The newborn must have been born alive
  • The newborn must have spontaneous breathing
  • The 1-minute Apgar score must be ≥7
  • The mother must be able to communicate with the research
  • The mother must have volunteered to participate in the study and given informed consent

You may not qualify if:

  • Meconium-stained or foul-smelling amniotic fluid
  • Episiotomy (3rd and 4th degree) and medical intervention during labor (vacuum, dystocia interventions, etc.)
  • Suspicion of congenital anomalies or genetic diseases in the newborn
  • History of known chronic diseases in the mother or baby (diabetes, hypertension, epilepsy, thyroid disease, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

May 8, 2026

First Posted

July 22, 2026

Study Start

April 11, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

November 2, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

The consent form submitted to the ethics committee provides participants with assurance that their data will not be shared. Therefore, it is not being shared.

Locations