Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ashish Kc
ORCID ID
http://orcid.org/0000-0002-0541-4486
Contact details
UNICEF
UN House
Pulchowk
Lalitpur
P.O Box 1187
Nepal
Type
Scientific
Additional contact
Prof Nalini Singhal
ORCID ID
Contact details
Department of Pediatrics
University of Calgary
Calgary
Alberta
+403
Canada
Type
Scientific
Additional contact
Dr Mats Målqvist
ORCID ID
Contact details
Department of Women's and Children's Health
International Maternal and Child Health
Uppsala University Hospital
Drottininggatan 4
Uppsala
+46
Sweden
Type
Scientific
Additional contact
Dr Ola Andersson
ORCID ID
http://orcid.org/0000-0002-3972-0457
Contact details
Department of Women's and Children's Health
International Maternal and Child Health
Uppsala University Hospital
Drottininggatan 4
Uppsala
+46
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Nepal Health Research Council, 21/01/2016, ref: 92/2015
Study design
Single-centre randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Phase
Drug names
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 trial start date
10/04/2016
Overall trial end date
15/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
755 participants in each group
Total final enrolment
1500
Participant exclusion criteria
1. Antepartum Stillbirth
2. Intrapartum stillbirth
3. Congenital anomaly
4. Multiple gestation
5. Neonate not breathing at birth
Recruitment start date
15/04/2016
Recruitment end date
30/07/2016
Locations
Countries of recruitment
Nepal
Trial participating centre
Paropakar Maternity and Women's Hospital
Thapathali
Kathmandu
P.O Box 1187
Nepal
Sponsor information
Organisation
Uppsala University Hospital
Sponsor details
International Maternal and Child Health
Department of Women’s and Children’s Health
Uppsala
SE-751 85
Sweden
+46 18 611 59 84
kbh@kbh.uu.se
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
UNICEF
Alternative name(s)
United Nations Children's Emergency Fund
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United States of America
Funder name
Swedish Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swedisih Society of Medical Research (Svenska Sällskapet för Medicinsk Forskning)
Alternative name(s)
Swedish Society for Medical Research, SSMF
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
Sweden
Results and Publications
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
Intention to publish date
15/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31161042 (added 05/06/2019)