Condition category
Circulatory System
Date applied
29/03/2016
Date assigned
05/04/2016
Last edited
13/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

www.kbh.uu.se/imch

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

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

professional associations and societies

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes