Comparison of delayed cord clamping and umbilical cord milking in term infants
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To compare the level of Haemoglobin at 72 hours in term infants i.e ≥ 37weeks between Delayed cord clamping and Umbilical cord milking in term infants
Study Overview
Brief Summary
Randomized controlled trial study will be conducted on all term neonates i.e Gestational age ≥ 37weeks delivered either through vaginal delivery or Lower segment caesarean section in labour room and labour ot
Upon arrival in the delivery room, equipment check will be done and universal precautions be taken. Team briefing and roles will be discussed.
After delivery, the babies born out of normal vaginal delivery will be held below the level of vaginal introitus and those born out of caesarean section will be positioned between mother’s thigh.
For Group A: Umbilical cord will be clamped 10cm distance from the umbilical stump at atleast 60seconds which will be counted using stopwatch with help of a staff nurse.
For Group B : Milking of the available length of the cord will be done over 4 times towards the baby from the vaginal introitus (in vaginal delivery) or from abdominal incisional site in case of caesarean section will be done and then the cord will be clamped and cut.
Immediately following delivery, the process of evaluation, decision and action (resuscitation) begins in following order.
Newborn will be placed on warming table, dried, suctioning if necessary and assessment of supplemental oxygen will be done. At birth respiratory distress will be assessed using downes score. Downes score ≥ 2 will be admitted for NICU for further management. At 30minutes heart rate and respiratory rate will be reassessed by auscultation and chest rise movement.
All babies will be screened for TFT at 72hours of life and at that time 4ml of venous sample will be collected and hemoglobin, hematocrit and total serum bilirubin levels will be measured.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 9.00 Month(s) to 12.00 Month(s) (—)
- Sex
- Female
Inclusion Criteria
- •Gestational age ≥ 37weeks Singleton pregnancy.
Exclusion Criteria
- •Birth asphyxia Preterm infants Twin gestation Placental insuffiencies Placenta praevia Abruption placenta Non vigorous babies Rh negative pregnancy Congential anomalies on antenatal scan Downes Score more than or Equal to 1.
Outcomes
Primary Outcomes
To compare the level of Haemoglobin at 72 hours in term infants i.e ≥ 37weeks between Delayed cord clamping and Umbilical cord milking in term infants
Time Frame: 72 hours
Secondary Outcomes
- To compare the hemodynamic(HR,RR,SPO2), other haematological(HCT, TSB) & clinical parameters between delayed cord clamping & umbilical cord milking in term infants.
Investigators
THAMIZHARASAN G
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL