Effect of timing of cord clamping in newborns during first 10 minutes of birth

• Register: ISRCTN
• Last refreshed on: 1 July 2019
• Main ID: ISRCTN10944304
• Date of registration: 05/04/2016
• Prospective Registration: Yes
• Primary sponsor: Uppsala University Hospital
• Public title: Effect of timing of cord clamping in newborns during first 10 minutes of birth
• Scientific title: Effect of timing of cord clamping in the healthy late preterm and term neonate on heart rate during first 10 minutes of birth: A randomized controlled study in a hospital of Nepal
• Date of first enrolment: 15/04/2016
• Target sample size: 1510
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10944304
• Study type: Interventional
• Study design: Single-centre randomised parallel trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Nepal

Contacts

• Name: Ashish Kc

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women in active labour coming for delivery in the Maternal Newborn Service Center (MNSC)
2. Normal vaginal delivery
3. Women with no complication during delivery
4. Fetal Heart Rate (FHR=100=160bpm)
5. Women with gestational age (=33 weeks)

Exclusion criteria:
1. Antepartum Stillbirth
2. Intrapartum stillbirth
3. Congenital anomaly
4. Multiple gestation
5. Neonate not breathing at birth


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Neonatal heart rate
Circulatory System
Neonatal heart rate

Intervention(s)

Participants will be randomly assigned to one of two parallel groups in a 1:1 ratio a few minutes before delivery using envelope randomisation.

For all women, once they go into labour they are transferred to the Maternal and Newborn Service Center and the surveillance officer at the MNSC will place a Moyo’s Fetal Heart Rate Monitor in the mother’s abdomen to continuously monitor the fetal heart rate. A surveillance officer will be dedicated to each women to monitor the fetal heart rate and ensure attachment of the Moyo’s FHR monitor. Another surveillance officer, will be present at the time of delivery of infant’s shoulder to cord clamping using a stopwatch. Immediately after the delivery of the baby, the Moyo’s FHR monitor will be placed by another SO in the baby’s precordium to monitor the heart rate of the baby until 10 minutes of birth as well as time of first cry or breathe of the baby. The nurse-midwife will place the baby on the mother’s abdomen as routine procedure until the cord was clamped.

Group 1: In the early-clamping group, the SO will inform the nurse-midwife when 60 seconds was approaching and informed that cord should be clamped if not done earlier.
Group 2: In the delayed-clamping group, the SO will inform the nurse-midwife when 180 seconds had passed and the cord should be clamped.

Primary Outcome(s)

Neonatal Heart rate measured using a Moyo’s Fetal Heart Rate Monitor at continuously from the time of birth until 10 minutes of birth and 1, 3 and 5 minute.

Secondary Outcome(s)

1. Baby’s condition is measured using Apgar score at 1, 5 and 10 minutes
2. Time of establishment of spontaneous breathing is measured in seconds from the time of birth until 10 minutes
3. Neonatal Heart rate measured using a 1, 3, 5 and 10 minutes
4. Neonatal Heart rate measured using Massimo pulse oximeter continuously from the time of birth until 10 minutes of birth
5. Neonatal blood oxygen saturation measured using a Massimo pulse oximeter at 1, 3, 5 and 10 minutes
6. Neonatal blood oxygen saturation measured using a Massimo pulse oximeter continuously from the time of birth until 10 minutes of birth
7. Neonatal pulsatility index measured using a Massimo pulse oximeter at 1, 3, 5 and 10 minutes
8. Neonatal pulsatility index measured using a Massimo pulse oximeter continuously from the time of birth until 10 minutes of birth.
9. Body temperature (10-30 minutes after birth)
10. Respiratory distress at one hour after birth
11. Transcutaneous bilirubin at discharge
12. Baby’s condition at discharge (live/neonatal death)

Secondary ID(s)

N/A

Source(s) of Monetary Support

UNICEF, Swedish Research Council, Swedisih Society of Medical Research (Svenska Sällskapet för Medicinsk Forskning)

Ethics review

Status:
Approval date:
Contact:

Nepal Health Research Council, 21/01/2016, ref: 92/2015

Results

• Results available: Yes
• Date Completed: 15/10/2016