Multıdımensıonal Effects Of Delayed Cord Clampıng and Mılkıng on Placental Processes
DCC&MILKHEM P
1 other identifier
interventional
108
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedStudy Start
First participant enrolled
March 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedAugust 14, 2025
August 1, 2025
8 days
February 14, 2025
August 10, 2025
Conditions
Keywords
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
EXPERIMENTALDelayed 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
control group
NO INTERVENTIONstandart care grup
Interventions
Eligibility Criteria
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)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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