Condition category
Pregnancy and Childbirth
Date applied
21/04/2014
Date assigned
20/06/2014
Last edited
20/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catalina De Paco Matallana

ORCID ID

Contact details

Clinic University Hospital Virgen de la Arrixaca (Spain)
El Palmar (Murcia)
30120
Spain
+34 (0) 968395588
katydepaco@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Time of the third stage of labour after early cord clamping versus delayed cord clamping at term: a randomized study

Acronym

THISCLAMP

Study hypothesis

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

CEIC Clinic University Hospital Ethics Committee, Virgen de la Arrixaca; 2013

Study design

Randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2013

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant 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)

Recruitment start date

01/07/2013

Recruitment end date

31/05/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Clinic University Hospital Virgen de la Arrixaca (Spain)
El Palmar (Murcia)
30120
Spain

Sponsor information

Organisation

Murcia Health Service [Servicio Murciano de Salud (SMS)], Murcia (Spain)

Sponsor details

c/o Catalina De Paco Matallana/ MT Prieto-Sánchez
C/Alhelies 4. Edif. Al Andalus 3E
Murcia
30009
Spain
+34 (0) 676672617

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Murcia Health Service [Servicio Murciano de Salud (SMS)], Murcia (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes