Post Partum HemorrhagePhase 3NCT03463993
Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
A Phase 3 study testing Tranexamic Acid and Oxytocin in people with Post Partum Hemorrhage, run by University of Zimbabwe at 2 sites in Zimbabwe.
Trial summary
Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Tranexamic Acid and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 2 sitesZimbabwe
- Study dates
- 8 Apr 2018to 30 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman with signed informed consent***
- Understand English and/or Shona
- Estimated gestational age of 38 weeks or older
- Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour
- Live intrauterine fetus
- The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.
Who cannot join
- Placental Abruption
- Emergency caesarean section
- Current or previous history of significant disease including heart disease, liver, renal disorders
- Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
- History of epilepsy or seizures
- Autoimmune disease
Show all 11Show fewer
- Sickle cell disease
- Severe haemorrhagic disease
- Intrauterine fetal demise
- Eclampsia/HELLP syndrome
- Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery
Trial locations and contacts
2 sites in 1 country.
Zimbabwe2 sites
Harare Central Hospital
Harare
Parirenyatwa Group of Hospitals
Harare
About this study
Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.
Read more
Methods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.
The primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.
Discussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.
This large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.
Read the detailed description
RESEARCH QUESTION Does intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5 International Units (IU) result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section.
RATIONALE FOR THE RESEARCH Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe, PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.
In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.
RESEARCH OBJECTIVES
- To assess the impact of TXA (10mg/kg) given 10 minutes prior to elective caesarean section on postpartum blood loss
- To assess the potential adverse effects of TXA given 10 minutes prior to elective caesarean section Primary Outcome
- Incidence of PPH defined by blood loss equal to or exceeding 1000ml following elective caesarean section Secondary Outcomes
- Estimated blood loss during caesarean section
- Need for blood transfusion
- Use of additional uterotonics (such as oxytocin infusion or prostaglandins)
- TXA side effects
- Incidence of emergency surgery for PPH
- Duration of mother's postnatal hospital stay
- Neonatal outcome RESEARCH METHODOLOGY Research Design The aim of this study is to compare the effect of a low dose of TXA (10mg/kg) administered 10 minutes prior to elective caesarean section with prophylactic oxytocin administration, versus prophylactic oxytocin alone in an open label randomized clinical trial (RCT). An RCT is appropriate as it aims to reduce bias when testing this potentially new intervention.
Target Population Women undergoing elective caesarean sections at Harare and Parirenyatwa Hospitals based on set inclusion and exclusion criteria Inclusion criteria Pregnant woman with signed informed consent, who understand English and/or Shona, at estimated gestational age of 38 weeks or older, requiring Elective Caesarean Section, with a live intrauterine fetus.
Exclusion criteria Placental Abruption, emergency caesarean section, current or previous history of significant disease including heart disease, liver, renal disorders; known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke); history of epilepsy or seizures; autoimmune disease; sickle cell disease; severe haemorrhagic disease; intrauterine fetal demise; eclampsia/HELLP syndrome; administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery.
Sample Size A total sample size of 1,162 (581 per group) was calculated assuming a proportion of 2.1% PPH in the experimental group and 5.8% in the control group at 95% confidence interval and 90% power using Fleiss formula.
Subjects' state of physical health Healthy Intervention Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.
Assessment Questionnaire (attached). Vital signs (heart rate, blood pressure, respiratory rate) noted before surgery, immediately after placental delivery, and 1 to 2 hours after birth Full blood count (FBC), Urea \& electrolytes (u\&e) and liver function tests (LFTs) performed a day before delivery (routinely performed) U\&e, LFTs and FBC assessed 48 hours after delivery. Estimated blood loss (EBL) using the difference in hematocrit values taken prior to and 48 hours after caesarean delivery.
The investigators will also note the standard EBL based on estimates made by the anaesthetist after assessment of patient's linen and abdominal swabs.
RISKS AND BENEFITS The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus problem (25.4%), abdominal pain (12 - 19.8%), diarrhea (12.2%), fatigue (5.2%) and anaemia (5.6%).
The WOMAN Trial collaborators found that TXA actually reduces mortality due to bleeding in women with PPH with no adverse effects.
Tranexamic acid potentiates the blood clotting system and is used to treat and prevent bleeding. Use of TXA could potentially prevent PPH due to factors other than uterine atony, where uterotonics will not be effective.
COSTS AND COMPENSATION Study participants will not receive any compensation. The cost of TXA shall not be incurred by the study participants. They will bear their usual admission and caesarean section costs that they would otherwise have borne had they not participated in the study.
INFORMED CONSENT All subjects or legally authorized representatives for minors are expected to be give informed consent.
CONFIDENTIALITY ASSURANCES Information collected from the participants shall be confidential, will be assigned a code and no personal identifiers will be used. Information collected will be stored in a secure place only accessible to the researcher and assistants, as well as on a password-protected laptop computer. Consent forms will be kept for three years after the completion of the investigation unless stipulated otherwise by the Medical Research Council of Zimbabwe.
CONFLICTS OF INTERESTS The study is being carried out in partial fulfillment of the degree of Masters of Medicine in Obstetrics and Gynaecology. No other gains are to be obtained from carrying out the study.
COLLABORATIVE AGREEMENTS N/A INTENDED USE OF RESULTS The results of the study will be submitted to the College of Health Sciences as part of the requirements for completion of the degree of Masters of Medicine in Obstetrics and Gynaecology, and may be considered for publications to add to the current body of knowledge on the use of TXA.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Tranexamic Acid, Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.
OxytocinDrug
Also called Prophylactic oxytocin
5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Receives: Drug: Tranexamic Acid; Drug: Oxytocin |
| Group B | Active comparator | Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postpartum Haemorrhage (PPH)
PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation
Measured: Up to 48 hours post-caesarean section
Secondary outcomes (12)
Estimated Blood Loss
Blood loss during caesarean section based on visual estimation and calculation.
Measured: At caesarean section
Amount of Blood Transfused
Requirement by participant of blood transfusion
Measured: At caesarean section up to 48 hours post-caesarean section
Number of Participants With Use of Additional Uterotonics
Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol).
Measured: At caesarean section up to 48 hours post-caesarean section
Number of Participants With Tranexamic Acid Side Effects
Number of participants with adverse effects related to tranexamic acid use
Measured: From intravenous infusion of the drug up to 48 hours post-caesarean section
Number of Participants Requiring Emergency Surgery for PPH
Number of participants requiring emergency surgical procedures to manage any PPH that occurs
Measured: At caesarean section up to 48 hours post-caesarean section
Number of Days of Participants' Hospital Stay
The number of days the participant stayed in hospital from the date of admission to date of discharge from hospital.
Measured: From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Weight
Neonatal birth weight in grams
Measured: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery
APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores out of 10 at 1 minute and 5 minutes. A measure of the physical condition of a newborn infant. It is obtained by adding points (maximum score of 2, 1, or 0 as minimum score) for Appearance (0 - blue/pale, 1 - pink body, blue extremities, 2 - pink); Pulse (0 - absent heart rate, 1 - below 100 beats per minute, 2 - over 100 beats per minute), Grimace (Reflex irritability - 0 - floppy, 1 - minimal response to stimulation, 2- prompt response to stimulation), Activity (muscle tone: 0 - absent, 1 - Flexed arms and legs, 2 - active), Respiration ( 0 - absent, 1 - slow or irregular, 2 - vigorous cry). APGAR score at 1minute or 5 minute can be a minimum of of 0 (0+0+0+0+0) or maximum of 10 (2 for each parameter above).
Measured: Scores at 1 minute from time of delivery and at 5 minutes after delivery
Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit
Number of neonates requiring admission to the neonatal unit from time of delivery at caesarean section
Measured: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Number of Neonates Diagnosed With Jaundice
Number of neonates with clinical jaundice (yellowing of the skin or whites of the eyes)
Measured: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Thromboembolic Event
Number of neonatal thromboembolic events
Measured: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Death
Neonatal death that occurs
Measured: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start8 Apr 2018
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Partum HemorrhageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chipo Gwanzura, MD, University of Zimbabwe
- Investigators
- Tsungai Chipato, MBChB FRCOG, Study chair, Professor of Obstetrics and GynaecologyTaazadza Nhemachena, MBChB MMED, Study chair, Lecturer and ConsultantChipo Gwanzura, MBChB, Principal investigator, Registrar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463993
- Sponsor's protocol ID
- ETAPPPH
- Status last verified
- May 2022
- First submitted
- 17 Feb 2018
- Last updated
- 1 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT03463993
- Acronym / sponsor ID
- ETAPPPH
- Conditions
- Post Partum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 20 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.
Methods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.
The primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.
Discussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.
This large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.
Detailed description
RESEARCH QUESTION Does intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5 International Units (IU) result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section.
RATIONALE FOR THE RESEARCH Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe, PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.
In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.
RESEARCH OBJECTIVES
- To assess the impact of TXA (10mg/kg) given 10 minutes prior to elective caesarean section on postpartum blood loss
- To assess the potential adverse effects of TXA given 10 minutes prior to elective caesarean section Primary Outcome
- Incidence of PPH defined by blood loss equal to or exceeding 1000ml following elective caesarean section Secondary Outcomes
- Estimated blood loss during caesarean section
- Need for blood transfusion
- Use of additional uterotonics (such as oxytocin infusion or prostaglandins)
- TXA side effects
- Incidence of emergency surgery for PPH
- Duration of mother's postnatal hospital stay
- Neonatal outcome RESEARCH METHODOLOGY Research Design The aim of this study is to compare the effect of a low dose of TXA (10mg/kg) administered 10 minutes prior to elective caesarean section with prophylactic oxytocin administration, versus prophylactic oxytocin alone in an open label randomized clinical trial (RCT). An RCT is appropriate as it aims to reduce bias when testing this potentially new intervention.
Target Population Women undergoing elective caesarean sections at Harare and Parirenyatwa Hospitals based on set inclusion and exclusion criteria Inclusion criteria Pregnant woman with signed informed consent, who understand English and/or Shona, at estimated gestational age of 38 weeks or older, requiring Elective Caesarean Section, with a live intrauterine fetus.
Exclusion criteria Placental Abruption, emergency caesarean section, current or previous history of significant disease including heart disease, liver, renal disorders; known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke); history of epilepsy or seizures; autoimmune disease; sickle cell disease; severe haemorrhagic disease; intrauterine fetal demise; eclampsia/HELLP syndrome; administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery.
Sample Size A total sample size of 1,162 (581 per group) was calculated assuming a proportion of 2.1% PPH in the experimental group and 5.8% in the control group at 95% confidence interval and 90% power using Fleiss formula.
Subjects' state of physical health Healthy Intervention Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.
Assessment Questionnaire (attached). Vital signs (heart rate, blood pressure, respiratory rate) noted before surgery, immediately after placental delivery, and 1 to 2 hours after birth Full blood count (FBC), Urea \& electrolytes (u\&e) and liver function tests (LFTs) performed a day before delivery (routinely performed) U\&e, LFTs and FBC assessed 48 hours after delivery. Estimated blood loss (EBL) using the difference in hematocrit values taken prior to and 48 hours after caesarean delivery.
The investigators will also note the standard EBL based on estimates made by the anaesthetist after assessment of patient's linen and abdominal swabs.
RISKS AND BENEFITS The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus problem (25.4%), abdominal pain (12 - 19.8%), diarrhea (12.2%), fatigue (5.2%) and anaemia (5.6%).
The WOMAN Trial collaborators found that TXA actually reduces mortality due to bleeding in women with PPH with no adverse effects.
Tranexamic acid potentiates the blood clotting system and is used to treat and prevent bleeding. Use of TXA could potentially prevent PPH due to factors other than uterine atony, where uterotonics will not be effective.
COSTS AND COMPENSATION Study participants will not receive any compensation. The cost of TXA shall not be incurred by the study participants. They will bear their usual admission and caesarean section costs that they would otherwise have borne had they not participated in the study.
INFORMED CONSENT All subjects or legally authorized representatives for minors are expected to be give informed consent.
CONFIDENTIALITY ASSURANCES Information collected from the participants shall be confidential, will be assigned a code and no personal identifiers will be used. Information collected will be stored in a secure place only accessible to the researcher and assistants, as well as on a password-protected laptop computer. Consent forms will be kept for three years after the completion of the investigation unless stipulated otherwise by the Medical Research Council of Zimbabwe.
CONFLICTS OF INTERESTS The study is being carried out in partial fulfillment of the degree of Masters of Medicine in Obstetrics and Gynaecology. No other gains are to be obtained from carrying out the study.
COLLABORATIVE AGREEMENTS N/A INTENDED USE OF RESULTS The results of the study will be submitted to the College of Health Sciences as part of the requirements for completion of the degree of Masters of Medicine in Obstetrics and Gynaecology, and may be considered for publications to add to the current body of knowledge on the use of TXA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Tranexamic Acid, Drug: OxytocinParticipants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. |
| Group B | Active comparator | Drug: OxytocinParticipants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant woman with signed informed consent***
- Understand English and/or Shona
- Estimated gestational age of 38 weeks or older
- Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour
- Live intrauterine fetus
Key exclusion criteria (11 listed)
- Placental Abruption
- Emergency caesarean section
- Current or previous history of significant disease including heart disease, liver, renal disorders
- Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
- History of epilepsy or seizures
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 |
|---|---|---|
| Tranexamic AcidAlso: TXATXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. | Drug | Group A |
| OxytocinAlso: Prophylactic oxytocin5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section. | Drug | Group A, Group B |
Primary outcome
Number of Participants With Postpartum Haemorrhage (PPH)
Time frame: Up to 48 hours post-caesarean section
PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation
12 secondary outcomes
Estimated Blood Loss
Time frame: At caesarean section
Amount of Blood Transfused
Time frame: At caesarean section up to 48 hours post-caesarean section
Number of Participants With Use of Additional Uterotonics
Time frame: At caesarean section up to 48 hours post-caesarean section
Number of Participants With Tranexamic Acid Side Effects
Time frame: From intravenous infusion of the drug up to 48 hours post-caesarean section
Number of Participants Requiring Emergency Surgery for PPH
Time frame: At caesarean section up to 48 hours post-caesarean section
Number of Days of Participants' Hospital Stay
Time frame: From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Weight
Time frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery
Time frame: Scores at 1 minute from time of delivery and at 5 minutes after delivery
Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit
Time frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Number of Neonates Diagnosed With Jaundice
Time frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Thromboembolic Event
Time frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Neonatal Outcome - Death
Time frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors
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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.
Tsungai Chipato, MBChB FRCOG study chair
Professor of Obstetrics and Gynaecology
Taazadza Nhemachena, MBChB MMED study chair
Lecturer and Consultant
Chipo Gwanzura, MBChB principal investigator
Registrar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid and Oxytocin in people with Post Partum Hemorrhage, run by University of Zimbabwe at 2 sites in Zimbabwe.
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 6 inclusion and 11 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zimbabwe. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Postpartum Haemorrhage (PPH) (time frame: Up to 48 hours post-caesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2022.