Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.

Official Title
-----------------
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Procedure: Delayed cord clamping
* Procedure: Milking of the cord


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation Women ages 18 and older Exclusion Criteria: Planned vaginal breech delivery Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery) Fetal death in utero Red cell isoimmunization Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization Placenta previa or other known abnormal placentation (e.g. placenta accreta)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed cord clamping<br>Delayed cord clamping for 30 seconds | Procedure: Delayed cord clamping<br>* Delay cord clamping for 30 seconds after birth<br>|
| Experimental: Milking of the cord<br>Milking of the cord 4 times in 10 seconds | Procedure: Milking of the cord<br>* Milking of the cord 4 times in 10 seconds<br>|
| No Intervention: Immediate cord clamping<br>Immediate cord clamping after delivery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Neonatal Event | composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home | up to 24 weeks after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal estimated blood loss | Estimated blood loss at delivery | up to 1 hour after delivery | 
| Any grade intraventricular hemorrhage |  | up to 24 weeks after birth | 
| Severe intraventricular hemorrhage (grade 3 or 4) |  | up to 24 weeks after birth | 
| Periventricular leukomalacia |  | up to 24 weeks after birth | 
| Bronchopulmonary dysplasia |  | up to 24 weeks after birth | 
| Peak transcutaneous and/or serum bilirubin concentrations |  | up to 24 weeks after birth | 
| Phototherapy | Requirement and length of phototherapy | up to 24 weeks after birth | 
| Ionotropic support | Requirement and length of ionotropic support | up to 24 weeks after birth | 
| Neonatal intesive care unit (NICU) length of stay |  | up to 24 weeks after birth | 
| Sepsis |  | up to 24 weeks after birth | 
| Necrotizing enterocolitis |  | up to 24 weeks after birth | 
| Respiratory distress syndrome |  | up to 24 weeks after birth | 
| Number of blood transfusions while in the neonatal intensive care unit |  | up to 24 weeks after birth | 
| Ventilator time |  | up to 24 weeks after birth | 
| Apgar score <7 at 5 minutes |  | at 5 minutes after birth | 
| Umbilical cord pH < 7.0 |  | up to 30 minutes after birth | 
| Blood pressure on admission to neonatal intensive care unit |  | at 30 minutes after birth | 
| Polycythemia |  | up to 24 hours of life | 
| Hematocrit on admission to neonatal intensive care unit |  | up to 4 hours after birth | 
| Neonatal death |  | up to 24 weeks of life | 
| Length of 3rd stage of labor | Time period between delivery of the baby and delivery of the placenta | up to 1 hour after birth | 
| Use of uterotonic agents |  | up to 1 hour after birth | 
| Maternal blood transfusion |  | up to 5 days after delivery | 
| Manual removal of placenta |  | up to 1 hour after birth | 
| Operating time for cesarean delivery |  | up to 3 hours after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delayed cord clamping, Umbilical cord, Preterm, Cord milking