Cesarean Section ComplicationsNCT03793153
A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
A study testing Uterine Cooling Technique in people with Cesarean Section Complications and Intrapartum Hemorrhage, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Intrapartum Hemorrhage, Postpartum Hemorrhage
- What is being tested?
- Uterine Cooling Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Dec 2018to 25 Mar 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy at term between 38±5 days and 40 weeks.
- Elective planned or emergency repeated lower segment cesarean sections(LSCS).
- Pregnant women who will accept to be in the study, and have giveninformed consent.
Who cannot join
- Women who refuse to be in the study, and women who are unable to consentdue to emergent nature of the cesarean section will be excluded. Women whoare unable to understand the nature of the study due to mental illness, mentalretardation, medical condition, or other communication barrier will be excluded,or who with severe medical and surgical complications as any of the followingwill be excluded :
- Heart, liver, kidney, or brain diseases, and blood disorders.
- Abruptio placenta, and placental abnormalities or accrete syndromes.
- Polyhydraminos, macrosomia, or preeclampsia.
- History of thromboembolic disorders, or severe anemia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Cairo
About this study
Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it.
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 caesarean delivery is increasing, and the average blood loss during caesarean delivery (1000 mL) is double the amount lost during vaginal delivery (500 mL).
Caesarean section (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 caesarean section, 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. Indeed we need to reduce the bleeding during and after caesarean sections aiming for reducing the morbidity and mortality rate due to obstetric hemorrhage, which can be life threatening.
The hematocrit level falls by 10% and blood transfusion is required in 6% of women undergoing caesarean delivery versus 4% of women who have a vaginal birth. Numerous methods for performing caesarean section exist targeting a safe delivery for the infant with minimum maternal morbidity. Operative morbidity includes hemorrhage, anemia, and blood products transfusion may be required associated with many risks and complications.
Women who undergo a caesarean delivery are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent cesarean, 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.
The uterus is a smooth muscle whose contraction is modulated most directly by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus and beneath the placenta enlarge to provide adequate perfusion to the placenta. After separation of the placenta the uterine smooth muscle cells contract in a pincer-like action to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately 4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000 cesarean sections require hysterectomy to control bleeding.
Release of calcium ions from sarcoplasmic reticulum stores is the immediateinitiator of contraction, and calcium's diffusion from the muscle filaments andre-uptake by the sarcoplasmic reticulum results in relaxation of contraction. Insome smooth muscles cold enhances contraction; perhaps by slowing the re-uptake of calcium.
- Conditions
- Cesarean Section Complications, Intrapartum Hemorrhage, Postpartum Hemorrhage, Atony, Uterine
- Being tested
- Uterine Cooling Technique
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Cooling TechniqueProcedure or surgery
Also called Hetta-UCT
Standard LSCS will be done except immediatelyfollowing delivery of the fetus the uterus will beexternalized in the usual fashion and the body of theuterus cephalad to the hysterotomy incision will bewrapped in sterile surgical towels saturated in sterile,iced normal saline. These towels will come from asterile cooling pot set to 30 degrees Fahrenheit. Theskin of the abdomen will be draped to prevent contactwith the cold towels. Iced saline-soaked towels will bekept in place for a minimum of 5 minutes and replacedat the discretion of the attending obstetrician until thehysterotomy is closed and the uterus is replaced intothe patient's abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard Lower Segment Cesarean Section (LSCS) will be done. |
| Study | Active comparator | Uterine Cooling Technique: Standard LSCS will be done except immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. The skin of the abdomen will be draped to prevent contact with the cold towels. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen. Receives: Procedure: Uterine Cooling Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative Blood Loss (ml)
Estimating Blood Loss during LSCS immediately after delivery of the fetus and prior to delivery of the placenta till closure of uterine incision.
Measured: 20 minutes
Post-operative Vaginal Blood Loss (ml)
Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.
Measured: 6 hours
Secondary outcomes (11)
Change in Pre- versus Post-operative Hemoglobin value.
Recording change in Pre- versus Post-operative Hemoglobin (g/dl) value.
Measured: 48 hours post operative period
Change in Pre- versus Post-operative Hematocrit value.
Recording change in Pre- versus Post-operative Hematocrit (%) value.
Measured: 48 hours post operative period
Use of extra Oxytocin (more than 5 i.u.).
Use of extra Oxytocin (more than 5 i.u.).
Measured: 20 minutes
Use of Methergine.
Use of Methergine.
Measured: 6 hours
Use of Misopristole.
Use of Misopristole.
Measured: 6 hours
Requirement of blood products.
Requirement of blood products during Intra- and 6 hours Post-LSCS.
Measured: 6 hours
Total blood loss greater than 1000 cc.
Total blood loss (ml) greater than 1000 cc.
Measured: 7 hours
Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.
Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.
Measured: 7 hours
Total time uterus wrapped during hysterotomy repair.
Total time (minutes) uterus wrapped during hysterotomy repair.
Measured: 30 minutes
Uterine temperature after wrap removal.
Uterine temperature (Fahrenheit) after wrap removal recorded by infrared thermometer.
Measured: Less than one minute
Patient temperature pre, intra, and postoperative.
Patient temperature (Fahrenheit) pre, intra, and during first 6 hours postoperative.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start19 Dec 2018
- Primary completion20 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amro M. Hetta, Al-Azhar University
- Investigators
- Amro M. Hetta, M. Sc., Principal investigator, OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar UniversityAbdallah K. Ahmed, MD, Study director, OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar UniversityMofeed F. Mohamed, MD, Study chair, OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793153
- Sponsor's protocol ID
- OB1
- Status last verified
- Apr 2019
- First submitted
- 31 Dec 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Goswami 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 24348295Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.
PubMed 12709915Wang 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 26226243Maged 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 26341174Ahmed 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 25068947Movafegh 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 21872857CRASH-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 20554319Silver 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 16738145Marshall 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 22071057Cahill 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 16846571Gungorduk 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 20979013Magann 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.
PubMed 16108235Tarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, Gavrychenko D. (2012): Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care, 16(Suppl 1): P439.
World Health Organization (2010): World health report (2010) Background Paper, No 30. Available at www.who.int/entity/healthsystems/topics/financing/healthreport/30Csectioncosts.pdf.
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 24974589
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
- ClinicalTrials.gov ID
- NCT03793153
- Acronym / sponsor ID
- OB1
- Conditions
- Cesarean Section Complications, Intrapartum Hemorrhage, Postpartum Hemorrhage, Atony, Uterine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 4 Jan 2019 (actual)
- 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.
Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it.
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 caesarean delivery is increasing, and the average blood loss during caesarean delivery (1000 mL) is double the amount lost during vaginal delivery (500 mL).
Caesarean section (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 caesarean section, 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. Indeed we need to reduce the bleeding during and after caesarean sections aiming for reducing the morbidity and mortality rate due to obstetric hemorrhage, which can be life threatening.
The hematocrit level falls by 10% and blood transfusion is required in 6% of women undergoing caesarean delivery versus 4% of women who have a vaginal birth. Numerous methods for performing caesarean section exist targeting a safe delivery for the infant with minimum maternal morbidity. Operative morbidity includes hemorrhage, anemia, and blood products transfusion may be required associated with many risks and complications.
Women who undergo a caesarean delivery are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent cesarean, 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.
The uterus is a smooth muscle whose contraction is modulated most directly by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus and beneath the placenta enlarge to provide adequate perfusion to the placenta. After separation of the placenta the uterine smooth muscle cells contract in a pincer-like action to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately 4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000 cesarean sections require hysterectomy to control bleeding.
Release of calcium ions from sarcoplasmic reticulum stores is the immediateinitiator of contraction, and calcium's diffusion from the muscle filaments andre-uptake by the sarcoplasmic reticulum results in relaxation of contraction. Insome smooth muscles cold enhances contraction; perhaps by slowing the re-uptake of calcium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard Lower Segment Cesarean Section (LSCS) will be done. |
| Study | Active comparator | Procedure: Uterine Cooling TechniqueUterine Cooling Technique: Standard LSCS will be done except immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. The skin of the abdomen will be draped to prevent contact with the cold towels. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy at term between 38±5 days and 40 weeks.
- Elective planned or emergency repeated lower segment cesarean sections(LSCS).
- Pregnant women who will accept to be in the study, and have giveninformed consent.
Key exclusion criteria (5 listed)
- Women who refuse to be in the study, and women who are unable to consentdue to emergent nature of the cesarean section will be excluded. Women whoare unable to understand the nature of the study due to mental illness, mentalretardation, medical condition, or other communication barrier will be excluded,or who with severe medical and surgical complications as any of the followingwill be excluded :
- Heart, liver, kidney, or brain diseases, and blood disorders.
- Abruptio placenta, and placental abnormalities or accrete syndromes.
- Polyhydraminos, macrosomia, or preeclampsia.
- History of thromboembolic disorders, or severe anemia.
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 |
|---|---|---|
| Uterine Cooling TechniqueAlso: Hetta-UCTStandard LSCS will be done except immediatelyfollowing delivery of the fetus the uterus will beexternalized in the usual fashion and the body of theuterus cephalad to the hysterotomy incision will bewrapped in sterile surgical towels saturated in sterile,iced normal saline. These towels will come from asterile cooling pot set to 30 degrees Fahrenheit. Theskin of the abdomen will be draped to prevent contactwith the cold towels. Iced saline-soaked towels will bekept in place for a minimum of 5 minutes and replacedat the discretion of the attending obstetrician until thehysterotomy is closed and the uterus is replaced intothe patient's abdomen. | Procedure or surgery | Study |
Primary outcome
Intra-operative Blood Loss (ml)
Time frame: 20 minutes
Estimating Blood Loss during LSCS immediately after delivery of the fetus and prior to delivery of the placenta till closure of uterine incision.
Post-operative Vaginal Blood Loss (ml)
Time frame: 6 hours
Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.
11 secondary outcomes
Change in Pre- versus Post-operative Hemoglobin value.
Time frame: 48 hours post operative period
Change in Pre- versus Post-operative Hematocrit value.
Time frame: 48 hours post operative period
Use of extra Oxytocin (more than 5 i.u.).
Time frame: 20 minutes
Use of Methergine.
Time frame: 6 hours
Use of Misopristole.
Time frame: 6 hours
Requirement of blood products.
Time frame: 6 hours
Total blood loss greater than 1000 cc.
Time frame: 7 hours
Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.
Time frame: 7 hours
Total time uterus wrapped during hysterotomy repair.
Time frame: 30 minutes
Uterine temperature after wrap removal.
Time frame: Less than one minute
Patient temperature pre, intra, and postoperative.
Time frame: 7 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 9 Apr 2019.
- Background: PubMed 24348295Goswami 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.
- Background: PubMed 12709915Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.
- Background: PubMed 26226243Wang 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.
- 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.
- 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 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 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 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.
- 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 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 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 16108235Magann 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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, M. Sc. principal investigator
OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Abdallah K. Ahmed, MD study director
OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Mofeed F. Mohamed, MD study chair
OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Cooling Technique in people with Cesarean Section Complications and Intrapartum Hemorrhage, run by Al-Azhar University 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 9 Apr 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Intra-operative Blood Loss (ml) (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 NCT03793153, which also lists 19 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 9 Apr 2019.