Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cesarean Delivery
- Sponsor
- Acibadem University
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Postpartum maternal hemorrhage
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
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.
Investigators
Esra Ozbasli
Assistant Professor
Acibadem University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Postpartum maternal hemorrhage
Time Frame: On postoperative day 0 and day 2
Preoperative and postoperative hemoglobin values will be recorded.
Secondary Outcomes
- Neonatal anemia(On postpartum day 2)
- Newborn positive pressure ventilation(Postpartum 5 days)
- Postpartum maternal anemia(İn postpartum 48 hours)
- Neonatal outcomes(Postpartum day 0)
- Newborn phototherapy need(In postpartum 2 weeks)
- Postpartum complaints(İn postpartum 48 hours)
- Neonatal jaundice(On postpartum day 2)
- Neonatal intensive care unit admission(In postpartum 5 days)
- Maternal outcomes(On postpartum day 2)