NCT06865391

Brief Summary

This study was conducted to evaluate the effects of delayed cord clamping and milking the umbilical cord of term babies after 90 seconds during vaginal birth on the newborn and the mother and to determine whether it is a suitable alternative method for cord management after birth. Methods: The study was conducted in the form of a randomized controlled design. The study was conducted in a hospital in eastern Turkiye between February -January 2025. The study was completed with 108 women who had vaginal delivery at term (DCC group n=36, UCM group n=36, control group n=36). Participants were assigned to groups by simple randomization. Data collection tools were used to collect demographic information, maternal hemoglobin, and hematocrit values, placental abruption time, newborn APGAR scores, umbilical cord pH levels, and day 7 hematological/biochemical parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

8 days

First QC Date

February 14, 2025

Last Update Submit

August 10, 2025

Conditions

Keywords

delayed cord clampingcord milkingplacentaclinical outcomemidwifery

Outcome Measures

Primary Outcomes (1)

  • APGAR

    APGAR scores,Developed in 1953 by Dr Virginia Apgar for the quantitative assessment of the vitality of the newborn, the scoring system is used in almost all neonatal units as an easy and rapid method to determine the condition of the child at birth. Its aim is to encourage closer observation and to provide a more precise assessment of the clinical status of infants. According to the Apgar scoring system, the newborn is assessed at 1 and 5 minutes after birth and if necessary, the scoring is repeated every 5 minutes. Apgar scoring is based on 5 objective parameters: 1. peak heart rate, 2. respiratory pattern, 3. muscle tone, 4. skin colour, 5. response to stimulation. Each parameter is given 0, 1 and 2 points. The scores given for each parameter are summed. Values between 710 points are considered healthy newborns, while 4-6 points are considered moderate depression and 0-3 points are considered severe depression.

    5 minutes after birth

Study Arms (2)

Experimental

EXPERIMENTAL

Delayed cord clamping (DCC) was defined as clamping the umbilical cord 90 seconds after birth. A stopwatch was used to record the time of all interventions and was noted in the study protocol. Umbilical Cord Milking (UCM) is the process of grasping the umbilical cord towards the newborn before cutting the umbilical cord and pushing the blood towards the newborn 3-4 times within 20 seconds." In this group, early cord clamping (\<30 seconds) was performed after birth from 25-30 cm ahead of the newborn for a total of 4 times. UCM, with one hand, the cord was pinched and held closest to the placental end, the other hand was used to milk blood towards the infant where at the umbilical endpoint the cord was held. This served as one milking motion. The cord was then released at the placental end and allowed to refill over 1 to 2 seconds between each milking motion. This was repeated a total of 4 times. After milking, the cord was clamped and cut, and the neonate was handed over to

Behavioral: Delayed cord clamping

control group

NO INTERVENTION

standart care grup

Interventions

Experimental

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsYES
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being 18 years of age and older,
  • having a single healthy newborn,
  • having a 37-42 week pregnancy,
  • having a baby in cephalic presentation, and
  • having a first birth (nulliparous).

You may not qualify if:

  • women with gestational anemia,
  • having abnormal placentation (such as bleeding, hypertension),
  • having a maternal hemorrhage,
  • having Rh isoimmunization, and
  • having a baby with a major congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş Merkez, K.maraş, 461000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 7, 2025

Study Start

March 20, 2025

Primary Completion

March 28, 2025

Study Completion

April 30, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations