Hemorrhage of Cesarean Section and/or Perineal WoundPhase 4NCT02739815
Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section
A Phase 4 study testing Normal Saline containing a prophylactic Antibiotic 1 g and Tranexamic Acid in people with Hemorrhage of Cesarean Section and/or Perineal Wound and Postpartum Hemorrhage, run by Talkha Central Hospital at 1 site in Egypt.
Trial summary
This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hemorrhage of Cesarean Section and/or Perineal Wound, Postpartum Hemorrhage
- What is being tested?
- Normal Saline containing a prophylactic Antibiotic 1 g and Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal average age of 20-40 years.
- Singleton pregnancy at term between 38±5 days and 40 weeks.
- Elective planned or emergency secondary lower segment caesarean sections (LSCS).
Who cannot join
- Women with severe medical and surgical complications as any of the following will be excluded :
- Heart, liver, kidney, or brain diseases, and blood disorders.
- Abruptio placenta, and placental abnormalities or accrete syndromes.
- Polyhydramnios, macrosomia, preeclampsia, or allergy to tranexamic acid.
- History of thromboembolic disorders, or severe anemia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University, Faculty of Medicine for Boys ( Cairo ), Al-Hussein University Hospital
Cairo, Cairo Governorate
About this study
Official title: Comparative Study For Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section: A Randomised Controlled Trial
This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS.
Read the detailed description
Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.
The incidence of CS is increasing, and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL). CS rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after CS, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Women who undergo a CS are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent CS, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.
TXA is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analogue; ε-aminocaproic acid. It competitively inhibits the activation of plasminogen to plasmin, by binding to specific sites of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clots. Its intravenous administration has been routinely used for many years to reduce or prevent excessive hemorrhage in various medical conditions or disorders (helping hemostasis), also during and after surgical procedures like benign hysterectomy, open heart surgeries, scoliosis surgery, oral surgery, liver surgeries, total hip or knee arthroplasty, and urology. It has been shown to be very useful and efficient in reducing blood loss and incidence of blood transfusion in these surgeries, and decreases the risk of death in bleeding trauma patients. It was also included in the World Health Organization (WHO) Model List of Essential Medicines.
About its role in CS, some recent studies showed that TXA has advantage and useful effect safely in reducing blood loss and requirement of additional ecbolics. Its doses used intravenously to reduce blood loss at CS were a bolus of 1gm, 10 mg/kg, or 15 mg/kg which had an advantage over 10 mg/kg in anemic parturients. No defined safe prophylactic intravenous TXA dose being found in searching literature having an advantage over other doses in reducing total blood loss especially at secondary uncomplicated LSCS.
- Being tested
- Normal Saline containing a prophylactic Antibiotic 1 g, Tranexamic Acid
- Keywords
- Caesarean Section, Tranexamic Acid, Postpartum Hemorrhage, Ecbolics
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline containing a prophylactic Antibiotic 1 gDrug
Also called Solution of Sodium Chloride 0.9 %
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Tranexamic AcidDrug
Also called TXA
Tranexamic acid
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Will receive a placebo (10 ml of distilled water) in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). Receives: Drug: Normal Saline containing a prophylactic Antibiotic 1 g |
| T1 | Active comparator | Will receive Tranexamic acid 15 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). Receives: Drug: Normal Saline containing a prophylactic Antibiotic 1 g; Drug: Tranexamic Acid |
| T2 | Active comparator | Will receive Tranexamic acid 20 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). Receives: Drug: Normal Saline containing a prophylactic Antibiotic 1 g; Drug: Tranexamic Acid |
| T3 | Active comparator | Will receive Tranexamic acid 25 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). Receives: Drug: Normal Saline containing a prophylactic Antibiotic 1 g; Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss Volume
Estimating Total Blood Loss Volume (ml) during and after Caesarean Section, up to 6 hours post-operative.
Measured: Up to 7 hours
Secondary outcomes (13)
Duration of surgery
Duration of Caesarean Section estimating (min)
Measured: Up to One hour
Hemoglobin level (Hb)
6 hours post-operative hemoglobin level (mg/dL) estimating.
Measured: 6 hours
Maternal weight (W)
2 hours post-operative maternal weight (kg) estimating
Measured: 2 hours
Hematocrit value (Hct)
6 hours post-operative hematocrit value (%) estimating.
Measured: 6 hours
Need for blood or blood products transfusion
Need for other medical measures to arrest and manage bleeding (transfusion of blood or blood products)
Measured: Up to 6 hours
Need for additional ecbolics
Need for other medical measures to arrest and manage bleeding if there is a uterine atony (more than five units of intravenous Syntocinon®)
Measured: Up to 6 hours
Need for hysterectomy
Need for other surgical measures to arrest and manage bleeding (Hysterectomy)
Measured: Up to 6 hours
Need for uterine artery ligation
Need for other surgical measures to arrest and manage bleeding (Uterine artery ligation)
Measured: Up to 6 hours
Need for B-lynch
Need for other surgical measures to arrest and manage bleeding if there is a uterine atony (B-lynch)
Measured: Up to 6 hours
APGAR Score
APGAR Score as index for any neonatal side effects of medications given
Measured: Up to 30 minutes
Any sign for developing a thromboembolic disorder (Maternal)
As index for any maternal side effects of medications given
Measured: One week
Blood pressure
Measuring maternal blood pressure (mmHg) immediately postoperative and after 2 hours postoperative.
Measured: Up to 2 hours
Pulse rate
Measuring maternal blood puse rate (/minute) immediately postoperative and after 2 hours postoperative.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage of Cesarean Section and/or Perineal WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talkha Central Hospital
- Sponsor type
- Other government
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital
- Investigators
- Amro M. Hetta, MS Student, Principal investigator, Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYNMahmoud E. Mohammed, Professor, Study director, Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYNYehia A. Wafa, Chairman, Study chair, Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739815
- Sponsor's protocol ID
- OG1
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.
PubMed 24974589Gungorduk K, Yildirim G, Asicioglu O, Gungorduk OC, Sudolmus S, Ark C. Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study. Am J Perinatol. 2011 Mar;28(3):233-40. doi: 10.1055/s-0030-1268238. Epub 2010 Oct 26.
PubMed 20979013Cahill AG, Stamilio DM, Odibo AO, Peipert JF, Ratcliffe SJ, Stevens EJ, Sammel MD, Macones GA. Is vaginal birth after cesarean (VBAC) or elective repeat cesarean safer in women with a prior vaginal delivery? Am J Obstet Gynecol. 2006 Oct;195(4):1143-7. doi: 10.1016/j.ajog.2006.06.045. Epub 2006 Jul 17.
PubMed 16846571Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.
PubMed 22071057Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
PubMed 16738145Yehia AH, Koleib MH, Abdelazim IA, Atik A. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial. Asian Pacific Journal of Reproduction. 2014 Mar 31;3(1):53-6.
Tarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, Gavrychenko D. Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care. 2012;16(Suppl 1):P439.
Mayur G, Purvi P, Ashoo G, Pankaj D. Efficacy of tranexamic acid in decreasing blood loss during and after cesarean section: a randomized case controlled prospective study. J Obstet Gynecol India. 2007;57(3):227-30.
CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319Movafegh A, Eslamian L, Dorabadi A. Effect of intravenous tranexamic acid administration on blood loss during and after cesarean delivery. Int J Gynaecol Obstet. 2011 Dec;115(3):224-6. doi: 10.1016/j.ijgo.2011.07.015. Epub 2011 Aug 27.
PubMed 21872857Ahmed MR, Sayed Ahmed WA, Madny EH, Arafa AM, Said MM. Efficacy of tranexamic acid in decreasing blood loss in elective caesarean delivery. J Matern Fetal Neonatal Med. 2015 Jun;28(9):1014-8. doi: 10.3109/14767058.2014.941283. Epub 2014 Jul 28.
PubMed 25068947Maged AM, Helal OM, Elsherbini MM, Eid MM, Elkomy RO, Dahab S, Elsissy MH. A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery. Int J Gynaecol Obstet. 2015 Dec;131(3):265-8. doi: 10.1016/j.ijgo.2015.05.027. Epub 2015 Aug 15.
PubMed 26341174Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.
PubMed 26226243Goswami U, Sarangi S, Gupta S, Babbar S. Comparative evaluation of two doses of tranexamic acid used prophylactically in anemic parturients for lower segment cesarean section: A double-blind randomized case control prospective trial. Saudi J Anaesth. 2013 Oct;7(4):427-31. doi: 10.4103/1658-354X.121077.
PubMed 24348295Gibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study For Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02739815
- Acronym / sponsor ID
- OG1
- Keywords
- Caesarean Section, Tranexamic Acid, Postpartum Hemorrhage, Ecbolics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Talkha Central HospitalOther government
- Collaborators
- Al-Azhar University
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS.
Detailed description
Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.
The incidence of CS is increasing, and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL). CS rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after CS, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Women who undergo a CS are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent CS, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.
TXA is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analogue; ε-aminocaproic acid. It competitively inhibits the activation of plasminogen to plasmin, by binding to specific sites of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clots. Its intravenous administration has been routinely used for many years to reduce or prevent excessive hemorrhage in various medical conditions or disorders (helping hemostasis), also during and after surgical procedures like benign hysterectomy, open heart surgeries, scoliosis surgery, oral surgery, liver surgeries, total hip or knee arthroplasty, and urology. It has been shown to be very useful and efficient in reducing blood loss and incidence of blood transfusion in these surgeries, and decreases the risk of death in bleeding trauma patients. It was also included in the World Health Organization (WHO) Model List of Essential Medicines.
About its role in CS, some recent studies showed that TXA has advantage and useful effect safely in reducing blood loss and requirement of additional ecbolics. Its doses used intravenously to reduce blood loss at CS were a bolus of 1gm, 10 mg/kg, or 15 mg/kg which had an advantage over 10 mg/kg in anemic parturients. No defined safe prophylactic intravenous TXA dose being found in searching literature having an advantage over other doses in reducing total blood loss especially at secondary uncomplicated LSCS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Normal Saline containing a prophylactic Antibiotic 1 gWill receive a placebo (10 ml of distilled water) in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). |
| T1 | Active comparator | Drug: Normal Saline containing a prophylactic Antibiotic 1 g, Drug: Tranexamic AcidWill receive Tranexamic acid 15 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). |
| T2 | Active comparator | Drug: Normal Saline containing a prophylactic Antibiotic 1 g, Drug: Tranexamic AcidWill receive Tranexamic acid 20 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). |
| T3 | Active comparator | Drug: Normal Saline containing a prophylactic Antibiotic 1 g, Drug: Tranexamic AcidWill receive Tranexamic acid 25 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Maternal average age of 20-40 years.
- Singleton pregnancy at term between 38±5 days and 40 weeks.
- Elective planned or emergency secondary lower segment caesarean sections (LSCS).
Key exclusion criteria (5 listed)
- Women with severe medical and surgical complications as any of the following will be excluded :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline containing a prophylactic Antibiotic 1 gAlso: Solution of Sodium Chloride 0.9 %500 ml of normal saline containing a prophylactic Antibiotic 1 g. | Drug | Placebo, T1, T2, T3 |
| Tranexamic AcidAlso: TXATranexamic acid | Drug | T1, T2, T3 |
Primary outcome
Total Blood Loss Volume
Time frame: Up to 7 hours
Estimating Total Blood Loss Volume (ml) during and after Caesarean Section, up to 6 hours post-operative.
13 secondary outcomes
Duration of surgery
Time frame: Up to One hour
Hemoglobin level (Hb)
Time frame: 6 hours
Maternal weight (W)
Time frame: 2 hours
Hematocrit value (Hct)
Time frame: 6 hours
Need for blood or blood products transfusion
Time frame: Up to 6 hours
Need for additional ecbolics
Time frame: Up to 6 hours
Need for hysterectomy
Time frame: Up to 6 hours
Need for uterine artery ligation
Time frame: Up to 6 hours
Need for B-lynch
Time frame: Up to 6 hours
APGAR Score
Time frame: Up to 30 minutes
Any sign for developing a thromboembolic disorder (Maternal)
Time frame: One week
Blood pressure
Time frame: Up to 2 hours
Pulse rate
Time frame: Up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Background: PubMed 24974589Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.
- Background: PubMed 20979013Gungorduk K, Yildirim G, Asicioglu O, Gungorduk OC, Sudolmus S, Ark C. Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study. Am J Perinatol. 2011 Mar;28(3):233-40. doi: 10.1055/s-0030-1268238. Epub 2010 Oct 26.
- Background: PubMed 16846571Cahill AG, Stamilio DM, Odibo AO, Peipert JF, Ratcliffe SJ, Stevens EJ, Sammel MD, Macones GA. Is vaginal birth after cesarean (VBAC) or elective repeat cesarean safer in women with a prior vaginal delivery? Am J Obstet Gynecol. 2006 Oct;195(4):1143-7. doi: 10.1016/j.ajog.2006.06.045. Epub 2006 Jul 17.
- Background: PubMed 22071057Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.
- Background: PubMed 16738145Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
- BackgroundYehia AH, Koleib MH, Abdelazim IA, Atik A. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial. Asian Pacific Journal of Reproduction. 2014 Mar 31;3(1):53-6.
- BackgroundTarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, Gavrychenko D. Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care. 2012;16(Suppl 1):P439.
- BackgroundMayur G, Purvi P, Ashoo G, Pankaj D. Efficacy of tranexamic acid in decreasing blood loss during and after cesarean section: a randomized case controlled prospective study. J Obstet Gynecol India. 2007;57(3):227-30.
- Background: PubMed 20554319CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Background: PubMed 21872857Movafegh A, Eslamian L, Dorabadi A. Effect of intravenous tranexamic acid administration on blood loss during and after cesarean delivery. Int J Gynaecol Obstet. 2011 Dec;115(3):224-6. doi: 10.1016/j.ijgo.2011.07.015. Epub 2011 Aug 27.
- Background: PubMed 25068947Ahmed MR, Sayed Ahmed WA, Madny EH, Arafa AM, Said MM. Efficacy of tranexamic acid in decreasing blood loss in elective caesarean delivery. J Matern Fetal Neonatal Med. 2015 Jun;28(9):1014-8. doi: 10.3109/14767058.2014.941283. Epub 2014 Jul 28.
- Background: PubMed 26341174Maged AM, Helal OM, Elsherbini MM, Eid MM, Elkomy RO, Dahab S, Elsissy MH. A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery. Int J Gynaecol Obstet. 2015 Dec;131(3):265-8. doi: 10.1016/j.ijgo.2015.05.027. Epub 2015 Aug 15.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amro M. Hetta, MS Student principal investigator
Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
Mahmoud E. Mohammed, Professor study director
Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
Yehia A. Wafa, Chairman study chair
Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline containing a prophylactic Antibiotic 1 g and Tranexamic Acid in people with Hemorrhage of Cesarean Section and/or Perineal Wound and Postpartum Hemorrhage, run by Talkha Central Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Blood Loss Volume (time frame: Up to 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02739815, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.