Condition category
Pregnancy and Childbirth
Date applied
16/08/2009
Date assigned
18/09/2009
Last edited
13/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gokhan Yildirim

ORCID ID

Contact details

Atakent Mah. Soyak Olypiakent Sitesi D10-57
K.Cekemece
Istanbul
34303
Turkey
gokhan73yildirim@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Intravenous tranexamic acid use in elective caesarean section: Does it reduce blood loss? A prospective randomised double-blind placebo controlled study

Acronym

Study hypothesis

We know that, during delivery, when the placenta separates from the uterine wall, the fibrinolytic activation of the maternal blood increases and this tends to reduce the potential of blood to clot. This activation can last up to 6 - 10 hours postpartum, causing more bleeding. According to this activation of the fibrinolytic system, we decided to use transexamic acid (TA) to reduce the blood loss in the management of elective caesarean section (C/S) because TA inhibits this activation, thereby reducing bleeding.

As of 13/04/2010 this record was updated to include an amendment to the anticipated start date of this trial. The initial anticipated start date provided at the time of registration was 01/05/2009.

Ethics approval

Istanbul Bakirkoy Women and Children Hospital’s Local Ethics Board approved on the 18th March 2009 (ref: 185)

Study design

Prospective randomised double-blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Elective caesarean section

Intervention

Following informed consent, simple randomisation using a random number table was performed by the investigational pharmacy staff. Infusion bags were prepared in accordance with randomisation and the bags labeled as A or B. One bag contained 1 g/10 mL tranexamic acid (Transamin, Fako Ilaclari A.S. Istanbul) diluted with 20 mL of 5 % glucose (Bag A, tranexamic group). The other bag contained only 20 mL of 5 % glucose (Bag B, placebo group).

Bag A was administered at least 10 minutes prior to skin incision (tranexamic acid 1 g/10 mL was given slowly intravenously over 5 minutes). After delivery of the neonate, 5 IU i.v. bolus of pre-prepared oxytocin was given by the anaesthetis. Then, 30 IU oxytocin in 500 mL of lactated Ringer's solution at a rate of 125 mL/h which was continued for 4 hours were given. An antibiotic, 1 g cefazolin diluted in 20 mL normal saline, was administered over a 5-minute period.

In the placebo group, 10 minutes before taking the skin incision 20 mL of 5% glucose was given slowly intravenously over 5 minutes. After delivery of the neonate, 5 IU i.v. bolus of pre-prepared oxytocin was given by the anaesthetist. Then, 30 IU oxytocin in 500 mL of lactated Ringer's solution at a rate of 125 mL/h which was continued for 4 hours were given. An antibiotic, 1 g cefazolin diluted in 20 mL normal saline, was administered over a 5-minute period. All caesarean sections were performed under general anaesthesia.

Intervention type

Drug

Phase

Phase I

Drug names

Transexamic acid (TA)

Primary outcome measures

Quantity of blood postpartum, measured from one day before the caesarean section and two days after the caesarean section

Secondary outcome measures

Measured from one day before the caesarean section and two days after the caesarean section:
1. Excessive bleeding rate
2. Blood transfusion
3. The use of additional uterotonic agents reflecting atony (such as an oxytocin infusion or Prostaglandin F2a)
4. Incidence of tranexamic acid side effects
5. Post-natal length of stay for the mother
6. Neonatal outcomes

Overall trial start date

01/06/2009

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects older than 38 weeks estimated gestational age
2. Requiring elective caesarean section
3. Females aged 20 - 40 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

660

Participant exclusion criteria

Any risk factor associated with an increased risk of postpartum haemorrhage:
1. Anaemia (Hb less than 7 g%)
2. Multiple gestation
3. Antepartum haemorrhage
4. Uterine fibroids
5. Polyhydramnios
6. Emergency caesarean section
7. A history of uterine atony and postpartum bleeding
8. Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy

Recruitment start date

01/06/2009

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Turkey

Trial participating centre

Atakent Mah. Soyak Olypiakent Sitesi D10-57
Istanbul
34303
Turkey

Sponsor information

Organisation

Istanbul Bakirkoy Women and Children Hospital (Turkey)

Sponsor details

Department of Obstetrics and Gynecology
Istanbul
34720
Turkey

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Istanbul Bakirkoy Women and Children Hospital (Turkey) - Department of Obstetrics and Gynecology

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