NCT02350179

Brief Summary

The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is Tranexamic acid effective in reducing blood loss during and after elective Caesarean section? The Research Hypothesis The TXA could be able to reduce blood loss during and after elective Caesarean section. The null hypothesis will therefore state that: There will be no difference between TXA and placebo in reducing blood loss during and after elective Caesarean section.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

January 1, 2015

Last Update Submit

February 7, 2015

Conditions

Hemorrhage of Cesarean Section and/or Perineal Wound

Outcome Measures

Primary Outcomes (1)

  • Amount of blood loss calculated using statistical measurements to determine the total decrease in HB and Hematocrit levels following the CS

    Assessment of the intra-operative blood loss will be started after the uterine incision by collection of the suctioned blood and by weighing surgical towels. Post-operative blood loss will be assessed during the first 24 hour by weighing the pads. HB level \& Hematocrit will be investigated before and 24 hours after surgery. The weight of the dry towels will be subtracted from the weight of wet towels and the weight of the blood will change in to volume using the formula {density of blood is 1060/m3; slightly denser then water so volume of the blood = weight multiply 0,9}). Sample size determination: Assuming a rate of intraoperative blood loss ranging between 650ml in group 1 \& 450ml in group 2 with a SD of 300ml, a sample size of 48 patients in each group is enough to detect such difference, if true, at 0,05 alpha error and 0,09 power of the test (Kemal, 2010).

    6 months

Study Arms (2)

cases

EXPERIMENTAL

Women assigned to the study group will receive 1 gr of Tranexamic acid injection (Kapron, AMOUN Pharmaceutical co.) given slowly I.V over 10 minutes before the operation.

Drug: Tranexamic Acid

control

PLACEBO COMPARATOR

The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.

Drug: Glucose

Interventions

Tranexamic AcidDRUG

This will be a prospective, randomized controlled trial that will be carried at Obstetrics and Gynecology Department, Ain Shams Maternity Hospital. The study will include 100 pregnant women with singleton fetus 38 or more weeks gestation who will be divided in to two groups. Study group will include 50 women and control group will include 50 women. Women assigned to the study group will receive 1 gr of TXA injection (Kapron, AMOUN Pharmaceutical co.) given slowly I.V over 10 minutes before the operation. The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.

Also known as: Efficacy of Tranexamic Acid
cases
GlucoseDRUG

The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.

control

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 20-40 with singleton fetus 38 or more weeks
  • Uncomplicated pregnancy, up to 3rd parity
  • Women undergoing scheduled elective C.S

You may not qualify if:

  • Causes of uterine over-distention such as polyhydramnios or macrosomia
  • Grand multi parity
  • Previous PPH (3 x risk) or previous history of retained placenta
  • Pre-eclampsia or pregnancy-induced hypertension
  • Maternal hypertension
  • Pre-existing maternal hemorrhagic conditions
  • Maternal diabetes mellitus
  • Abnormal placenta
  • Sensitivity to TXA
  • Women taking anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Related Publications (15)

  • American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.

    PMID: 17012482BACKGROUND

  • As AK, Hagen P, Webb JB. Tranexamic acid in the management of postpartum haemorrhage. Br J Obstet Gynaecol. 1996 Dec;103(12):1250-1. doi: 10.1111/j.1471-0528.1996.tb09638.x. No abstract available.

    PMID: 8968245BACKGROUND

  • Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.

    PMID: 3321402BACKGROUND

  • Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth Analg. 2010 May 1;110(5):1368-73. doi: 10.1213/ANE.0b013e3181d74898. Epub 2010 Mar 17.

    PMID: 20237047BACKGROUND

  • Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.

    PMID: 17302638BACKGROUND

  • Bingham D. Obstetric hemorrhage-related maternal mortality and morbidity. J Womens Health (Larchmt). 2012 Sep;21(9):901-2. doi: 10.1089/jwh.2012.3873. No abstract available.

    PMID: 22928671BACKGROUND

  • Bick D; National Collaborating Centre for Women's and Children's Health; National Institute for Clinical Excellence. Caesarean Section. Clinical Guideline. National Collaborating Centre for Women's and Children's Health: commissioned by the National Institute for Clinical Excellence. Worldviews Evid Based Nurs. 2004;1(3):198-9. doi: 10.1111/j.1524-475X.2004.04060.x. No abstract available.

    PMID: 17163898BACKGROUND

  • Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.

    PMID: 10400410BACKGROUND

  • Lu MC, Fridman M, Korst LM, Gregory KD, Reyes C, Hobel CJ, Chavez GF. Variations in the incidence of postpartum hemorrhage across hospitals in California. Matern Child Health J. 2005 Sep;9(3):297-306. doi: 10.1007/s10995-005-0009-3.

    PMID: 16132205BACKGROUND

  • Magann EF, Evans S, Hutchinson M, Collins R, Lanneau G, Morrison JC. Postpartum hemorrhage after cesarean delivery: an analysis of risk factors. South Med J. 2005 Jul;98(7):681-5. doi: 10.1097/01.SMJ.0000163309.53317.B8.

    PMID: 16108235BACKGROUND

  • Najmi RS, Rehan N. Prevalence and determinants of caesarean section in a teaching hospital of Pakistan. J Obstet Gynaecol. 2000 Sep;20(5):479-83. doi: 10.1080/014436100434640.

    PMID: 15512631BACKGROUND

  • Queenan JT. How to stop the relentless rise in cesarean deliveries. Obstet Gynecol. 2011 Aug;118(2 Pt 1):199-200. doi: 10.1097/AOG.0b013e3182266682. No abstract available.

    PMID: 21775834BACKGROUND

  • Vangen S, Bergsjo P. [Do women die from pregnancy these days?]. Tidsskr Nor Laegeforen. 2003 Dec 23;123(24):3544-5. Norwegian.

    PMID: 14691495BACKGROUND

  • Mathai M, Gulmezoglu AM, Hill S. Saving womens lives: evidence-based recommendations for the prevention of postpartum haemorrhage. Bull World Health Organ. 2007 Apr;85(4):322-3. doi: 10.2471/blt.07.041962. No abstract available.

    PMID: 17546315BACKGROUND

  • Zhang J, Liu Y, Meikle S, Zheng J, Sun W, Li Z. Cesarean delivery on maternal request in southeast China. Obstet Gynecol. 2008 May;111(5):1077-82. doi: 10.1097/AOG.0b013e31816e349e.

    PMID: 18448738BACKGROUND

MeSH Terms

Interventions

Tranexamic AcidGlucose

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Zarafshan M Raqeeb, MS

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zarafshan M Raqeeb, MS

CONTACT

zarafzubair@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

January 1, 2015

First Posted

January 29, 2015

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

EG(1)