Effect of timing of cord clamping in newborns during first 10 minutes of birth
| ISRCTN | ISRCTN10944304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10944304 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/03/2016
- Registration date
- 05/04/2016
- Last edited
- 05/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A baby’s heart rate is one of the most important indicators of good health at the time of birth. It can be used to assess whether a baby requires additional support for breathing, as a low heart rate (less than 100 beats per minute) is used as a sign to start ventilation (helping a baby to breathe using a breathing machine). At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps, and cutting between the clamps. It is thought that a low heart rate at birth can be caused by a lower amount of blood circulating around the baby’s body due to early umbilical cord clamping (when the umbilical cord is clamped 60 seconds or less after birth). By delaying cord clamping, it is possible that more blood is able to return to the baby’s heart which initiates a healthy heart rate of over 100 beats per minute (bpm). The aim of this study is to find out whether delaying clamping of the umbilical cord for more than 180 seconds can help to increase the newborn baby’s heart rate to more than 100 bpm.
Who can participate?
Healthy women who are about to give birth to a single baby.
What does the study involve?
Participants are randomly allocated to one of two groups. For all women, a special heart rate monitor is placed on their stomach just before giving birth to monitor their baby’s heart rate. After they have given birth, the baby is then place on their stomach until the umbilical cord is clamped and another heart rate monitor is placed on the baby’s chest for 10 minutes to continuously monitor the heart rate. The time until the baby starts breathing is also recorded in seconds. For participants in the first group, the umbilical cord is clamped 60 seconds after they have given birth. For participants in the second group, the umbilical cord is clamped 180 seconds after giving birth. The heart rates of the babies in each group and the time until they start breathing is then compared between the two groups.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with taking part in the study.
Where is the study run from?
Paropakar Maternity and Women's Hospital (Nepal)
When is the study starting and how long is it expected to run for?
April 2016 to October 2016
Who is funding the study?
UNICEF (USA)
Who is the main contact?
1. Dr Ashish Kc (scientific)
2. Professor Nalini Singhal (scientific)
3. Dr Ola Andersson (scientific)
Contact information
Scientific
UNICEF
UN House
Pulchowk
Lalitpur
P.O Box 1187
Nepal
 ORCID ID |
0000-0002-0541-4486 |
|---|
Scientific
Department of Pediatrics
University of Calgary
Calgary, Alberta
+403
Canada
Scientific
Department of Women's and Children's Health
International Maternal and Child Health
Uppsala University Hospital
Drottininggatan 4
Uppsala
+46
Sweden
Scientific
Department of Women's and Children's Health
International Maternal and Child Health
Uppsala University Hospital
Drottininggatan 4
Uppsala
+46
Sweden
| ORCID ID |
0000-0002-3972-0457 |
|---|
Study information
| Study design | Single-centre randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| 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 |
| Study objectives | Delaying the clamping of cord for more than 180 seconds will have more venous blood return to the heart and increase the heart rate to more than 100 bpm. |
| Ethics approval(s) | Nepal Health Research Council, 21/01/2016, ref: 92/2015 |
| Health condition(s) or problem(s) studied | Neonatal heart rate |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 10/04/2016 |
| Completion date | 15/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 755 participants in each group |
| Total final enrolment | 1500 |
| Key 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) |
| Key exclusion criteria | 1. Antepartum Stillbirth 2. Intrapartum stillbirth 3. Congenital anomaly 4. Multiple gestation 5. Neonate not breathing at birth |
| Date of first enrolment | 15/04/2016 |
| Date of final enrolment | 30/07/2016 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Kathmandu
P.O Box 1187
Nepal
Sponsor information
University/education
International Maternal and Child Health
Department of Women’s and Children’s Health
Uppsala
SE-751 85
Sweden
| Phone | +46 18 611 59 84 |
|---|---|
| kbh@kbh.uu.se | |
| Website | www.kbh.uu.se/imch |
"ROR" |
https://ror.org/01apvbh93 |
Funders
Funder type
Charity
Government organisation / International organizations
- Alternative name(s)
- United Nations Children's Fund, United Nations Children's Emergency Fund, Fonds des Nations Unies pour l'enfance, Fondo de las Naciones Unidas para la Infancia, صندوق الأمم المتحدة للطفولة, 联合国儿童基金会
- Location
- United States of America
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Swedish Society for Medical Research, SSMF
- Location
- Sweden
Results and Publications
| Intention to publish date | 15/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication of a study protocol and results paper in peer reviewed journals 2. Planned dissemination of the results in international neonatology conference in 2017 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/05/2019 | 05/06/2019 | Yes | No |
Editorial Notes
05/06/2019: Publication reference and total final enrolment added.
