Multıdımensıonal Effects Of Delayed Cord Clampıng and Mılkıng on Placental Processes

NCT ID: NCT06865391

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2025-04-30

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.

Detailed Description

Labor and the postpartum period are critical periods that can have long-term effects on both maternal and neonatal health. Evidence-based interventions implemented during this period play a significant role in maternal physiological recovery, placental abruption, neonatal health parameters, and long-term health bilical cord management (delayed cord clamping [DCC] and umbilical cord milking [UCM]) has become an important research topic in recent years regarding its effects on maternal and neonatal outcomes DCC is defined by clamping the umbilical cord after birth for a certain period of time, and it has been shown that this practice can increase neonatal hemoglobin and hematocrit levels and reduce the risk of neonatal anemia . At the same time, it has been reported that DCC is especially recommended to reduce iron deficiency anemia in low-income countries . However, there are also views that DCC may prolong the time to placental abruption and increase the risk of postpartum hemorrhage in the mother UCM is defined as the process of pushing blood in the umbilical cord to the newborn with mechanical movement. There are studies indicating that this method improves oxygen transport by increasing blood volume and reduces the risk of intraventricular hemorrhage while increasing cardiovascular stability in premature babiesHowever, there are conflicting results in the literature regarding the effects of this method on hyperbilirubinemia and hemoglobin increase The effects of these different methods in umbilical cord management on maternal hemoglobin and hematocrit levels, placental abruption time, neonatal hematological and biochemical parameters, and postpartum complications have been an important area of research . Studies have emphasized that there are important relationships between the duration of placental abruption and neonatal health indicators and that these processes should be examined in detail . It has been reported that providing additional blood volume, especially in premature babies, can improve neonatological parameters and have important effects on maternal health . Therefore, studies have emphasized that the relationships between the duration of placental abruption and the timing of separation signs and neonatal health indicators should be examined in detail .In this study, many outcomes such as placental abruption time, maternal hemoglobin and hematocrit levels, and neonatal hematological and biochemical parameters were evaluated in this context. Therefore, this study aims to provide evidence to make a significant contribution to the literature on umbilical cord management practices and to determine the place of these practices in clinical practice.

Conditions

18 Years and Over; Newborn Health; 37 or More Completed Weeks of Gestation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Delayed cord clamping

Intervention Type: BEHAVIORAL

control group

standart care grup

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Delayed cord clamping

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Gul OZTAS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş Merkez, K.maraş, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KahramanmaraşSIUI5

Identifier Type: -

Identifier Source: org_study_id