Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

July 31, 2021 updated by: Esra Ozbasli, Acibadem University

Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries

The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Late clamping of the umbilical cord has been shown to have positive effects such as higher neonatal hemoglobin level, higher iron stores in the newborn around three to six months, and better neurological development. In 2017, American College of Obstetricians and Gynecologists (ACOG) recommended a minimum 30-60 seconds delayed clamping of the cord after a minimum of 30-60 seconds, regardless of the delivery method, in both term and preterm newborns. In addition, optimal placental transfusion can be achieved due to strong uterine tonus in vaginal delivery. However, this is not possible due to decreased uterine tonus and time constraint in cesarean delivery. The main concern in delayed clamping and milking of the umbilical cord is the possibility of maternal anemia due to excessive maternal blood loss in the short term, the need for maternal blood transfusion or maternal intensive care support, and the possibility of conditions such as hyperbilirubinemia, symptomatic polycythemia, and long hospital stay that may cause the need for phototherapy in the newborn. Although there are many studies in the literature regarding the neonatal results of the clamping timing of the umbilical cord, there are a limited number of articles regarding the results in patients who underwent term elective cesarean section. The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sariyer
      • Istanbul, Sariyer, Turkey, 34457
        • Acibadem Maslak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • > 37 weeks uncomplicated singleton pregnancy
  • Elective cesarean delivery
  • Cesarean section under regional anesthesia

Exclusion Criteria:

  • < 37 weeks pregnancy
  • Surgery performed under general anesthesia
  • Emergent cesarean
  • Multiple pregnancy
  • Medically unstable mother or fetus
  • Uncontrolled maternal diabetes
  • Major congenital malformation of chromosomal abnormality of the fetus
  • Intrauterine growth retardation
  • Prenatal asphyxia suspicion
  • True knot in the umbilical cord
  • İn case of meconium aspiration syndrome suspicion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Delayed Clamping
In this group, the umbilical cord will be clamped 60 seconds after the baby is born.
Procedure: Delayed umbilical cord clamping
The umbilical cord will be clamped 60 seconds after the baby is born.
ACTIVE_COMPARATOR: Early Clamping
In this group, the umbilical cord will be clamped 15 seconds after the baby is born.
Procedure: Early umbilical cord clamping
The umbilical cord will be clamped 15 seconds after the baby is born.
ACTIVE_COMPARATOR: Milking Clamping
In this group in which the umbilical cord will be milked, the cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
Procedure: Milking of the umbilical cord
The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum maternal hemorrhage
Time Frame: On postoperative day 0 and day 2
Preoperative and postoperative hemoglobin values will be recorded.
On postoperative day 0 and day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum maternal anemia
Time Frame: İn postpartum 48 hours
Blood loss during surgery, need for blood transfusion after surgery will be recorded.
İn postpartum 48 hours
Neonatal outcomes
Time Frame: Postpartum day 0
Weight of the baby
Postpartum day 0
Postpartum complaints
Time Frame: İn postpartum 48 hours
Postpartum nausea, vomiting, headache, dyspnea will be recorded
İn postpartum 48 hours
Neonatal anemia
Time Frame: On postpartum day 2
Hematocrit levels of the newborn will be measured
On postpartum day 2
Neonatal jaundice
Time Frame: On postpartum day 2
Bilirubin levels of the newborn will be measured.
On postpartum day 2
Neonatal intensive care unit admission
Time Frame: In postpartum 5 days
Neonatal intensive care unit admissions in postpartum 5 days will be recorded.
In postpartum 5 days
Maternal outcomes
Time Frame: On postpartum day 2
Postpartum maternal blood pressure, pulse will be recorded
On postpartum day 2
Newborn phototherapy need
Time Frame: In postpartum 2 weeks
Need of newborn phototherapy in postpartum 2 weeks will be recorded.
In postpartum 2 weeks
Newborn positive pressure ventilation
Time Frame: Postpartum 5 days
Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.
Postpartum 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Director: Mete Gungor, MD, Prof., Acıbadem Mehmet Ali Aydınlar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2021

Primary Completion (ACTUAL)

July 25, 2021

Study Completion (ACTUAL)

July 29, 2021

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (ACTUAL)

March 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 31, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATADEK 2021-01/44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, statistical analysis might be shared when the study is completed upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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