Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2021-07-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome

NCT05951348

Umbilical Cord Milking

COMPLETED NA

Cord Milking in Elective Cesarean Section

NCT03668782

Placental Transfusion

UNKNOWN

The Impact of Early Versus Delayed Umbilical Cord Clamping in Preeclamptic Pregnant Patients During Cesarean Section

NCT04193345

Umbilical Cord Clamping

COMPLETED NA

The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section

NCT05948436

Postpartum Hemorrhage Cesarean Section Complications

COMPLETED NA

Interventions That Promote Exclusive Breastfeeding

NCT04052984

Breastfeeding, Exclusive

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Delivery Delayed Separation of Umbilical Cord

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Delayed Clamping

In this group, the umbilical cord will be clamped 60 seconds after the baby is born.

Group Type ACTIVE_COMPARATOR

Delayed umbilical cord clamping

Intervention Type PROCEDURE

The umbilical cord will be clamped 60 seconds after the baby is born.

Early Clamping

In this group, the umbilical cord will be clamped 15 seconds after the baby is born.

Group Type ACTIVE_COMPARATOR

Early umbilical cord clamping

Intervention Type PROCEDURE

The umbilical cord will be clamped 15 seconds after the baby is born.

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.

Group Type ACTIVE_COMPARATOR

Milking of the umbilical cord

Intervention Type PROCEDURE

The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Delayed umbilical cord clamping

The umbilical cord will be clamped 60 seconds after the baby is born.

Intervention Type PROCEDURE

Early umbilical cord clamping

The umbilical cord will be clamped 15 seconds after the baby is born.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes