Time of the THIrd Stage of labour after early cord CLAMPing versus delayed cord clamping at term
| ISRCTN | ISRCTN49161976 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49161976 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/04/2014
- Registration date
- 20/06/2014
- Last edited
- 20/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The optimal time to clamp the umbilical cord still remains controversial. Although delayed cord clamping after 30 seconds has significant health benefits, this practice is not widely used. The proposed advantages for early cord clamping are a reduction of postpartum haemorrhage (excessive bleeding following delivery) and also the possibility of analysing the acid-base status in the umbilical cord artery and vein after birth, which is very important for paediatricians and obstetricians. On the other hand, delayed cord clamping is associated with a reduction of anaemia in childbirth. However, there have been no studies regarding any differences between the time of the third stage of labour and the moment we clamp the umbilical cord. The aim of this study is to investigate any differences between the time of the third stage of labour and the umbilical cord clamping.
Who can participate?
Women who are expected to have a normal vaginal birth after 37 weeks of gestation.
What does the study involve?
Pregnant women will be randomly allocated to one of the two groups: either cord clamping within 10 seconds after birth or cord clamping at 2 minutes after birth. Also, the time of the third stage of labour will be measured and, in the meantime, blood will be taken from the umbilical cord artery and the umbilical cord vein. 48 hours after delivery, a maternal blood test will be also performed to find any differences between both groups of the study in terms of postpartum haemorrhage.
What are the possible benefits and risks of participating?
Risks to participants are minimal because the intervention on either the babies or the mothers is unlikely to cause any damage. All the babies will be born in a very safety environment with midwives and paediatricians if they are needed, as all interventions will be performed in normal deliveries.
Where is the study run from?
Clinic University Hospital Virgen de la Arrixaca (Spain).
When is the study starting and how long is it expected to run for?
The study ran from July 2013 to May 2014.
Who is funding the study?
Murcia Health Service (Spain).
Who is the main contact?
Dr Catalina De Paco Matallana
katydepaco@hotmail.com
Contact information
Scientific
Clinic University Hospital Virgen de la Arrixaca (Spain)
El Palmar (Murcia)
30120
Spain
| Phone | +34 (0) 968395588 |
|---|---|
| katydepaco@hotmail.com |
Study information
| Study design | Randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Time of the third stage of labour after early cord clamping versus delayed cord clamping at term: a randomized study |
| Study acronym | THISCLAMP |
| Study objectives | To evaluate the effect of timing of umbilical cord clamping on the timing of the third stage of labour in newborns at term. |
| Ethics approval(s) | CEIC Clinic University Hospital Ethics Committee, Virgen de la Arrixaca; 2013 |
| Health condition(s) or problem(s) studied | Topic: Reproductive Health, Disease: Reproductive Health & Childbirth, Paediatrics |
| Intervention | Particpants are randomized to two groups: 1. Early cord clamping: clamping of the cord within 10 seconds after birth 2. Delayed cord clamping: clamping of the cord 2 minutes after birth |
| Intervention type | Other |
| Primary outcome measure | Evaluation of the time of the third stage of labour in both groups of the study measured using a stopwatch. |
| Secondary outcome measures | Acid-base state in the umbilical artery and vein in both groups of the study. This is measured using Plastipak syringes for the blood collection from the umbilical cord and an automatic blood gas analyzer. |
| Overall study start date | 01/07/2013 |
| Completion date | 31/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | Women with singleton pregnancies will be eligible for the study if they are likely to have a non-instrumental vaginal delivery after 37 weeks gestation |
| Key exclusion criteria | 1. Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery) 2. Fetal growth restriction 3. Twin pregnancies 4. Maternal pathology (pregestational diabetes, severe cardiopathy, etc) 5. Infectious disease, hypertension and/or preeclampsia, obstetrics complications (abruptio, etc) |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 31/05/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
30120
Spain
Sponsor information
Hospital/treatment centre
c/o Catalina De Paco Matallana/ MT Prieto-Sánchez
C/Alhelies 4. Edif. Al Andalus 3E
Murcia
30009
Spain
| Phone | +34 (0) 676672617 |
|---|---|
"ROR" |
https://ror.org/055bn0x53 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
