Primary outcomeCount of participants· Up to 48 hours post-caesarean section
Number of Participants With Postpartum Haemorrhage (PPH)
| Group | Value (Participants) |
|---|---|
| Group A | 48 |
| Group B | 54 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
NCTNCT03463993 (opens ClinicalTrials.gov in a new tab)Other idETAPPPH
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 506 participants (actual)
- Sponsor
- University of Zimbabwe · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Zimbabwe
- Start
- 8 Apr 2018
- Primary completion
- 31 Dec 2018
- Completion
- 30 Jun 2019
- First posted
- 13 Mar 2018
- Last update posted
- 1 Jun 2022
- Conditions
- Post Partum Hemorrhage
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201820192020
- Ph 3
Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
NCT034639938 Apr 2018 to 30 Jun 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Tranexamic AcidDrug
- OxytocinDrug
Arms2
Experimental
Group A
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.
Active comparator
Group B
Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With Postpartum Haemorrhage (PPH)
Time frame · Up to 48 hours post-caesarean section
Registry description
PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation
Secondary outcomes(12)
Estimated Blood Loss
Time frame · At caesarean section
Registry description
Blood loss during caesarean section based on visual estimation and calculation.
Amount of Blood Transfused
Time frame · At caesarean section up to 48 hours post-caesarean section
Registry description
Requirement by participant of blood transfusion
Number of Participants With Use of Additional Uterotonics
Time frame · At caesarean section up to 48 hours post-caesarean section
Registry description
Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol).
Number of Participants With Tranexamic Acid Side Effects
Time frame · From intravenous infusion of the drug up to 48 hours post-caesarean section
Registry description
Number of participants with adverse effects related to tranexamic acid use
Number of Participants Requiring Emergency Surgery for PPH
Time frame · At caesarean section up to 48 hours post-caesarean section
Registry description
Number of participants requiring emergency surgical procedures to manage any PPH that occurs
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
Registry description
The number of days the participant stayed in hospital from the date of admission to date of discharge from hospital.
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
Registry description
Neonatal birth weight in grams
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
Registry description
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).
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
Registry description
Number of neonates requiring admission to the neonatal unit from time of delivery at caesarean section
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
Registry description
Number of neonates with clinical jaundice (yellowing of the skin or whites of the eyes)
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
Registry description
Number of neonatal thromboembolic events
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
Registry description
Neonatal death that occurs
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· At caesarean section
Estimated Blood Loss
| Group | Value (ml) | Spread |
|---|---|---|
| Group A | 483.73 | 182.56 |
| Group B | 479.61 | 139.49 |
Secondary outcomeMedian· At caesarean section up to 48 hours post-caesarean section
Amount of Blood Transfused
| Group | Value (units of blood given) |
|---|---|
| Group A | 1.5 |
| Group B | 2.5 |
Secondary outcomeCount of participants· At caesarean section up to 48 hours post-caesarean section
Number of Participants With Use of Additional Uterotonics
| Group | Value (Participants) |
|---|---|
| Group A | 38 |
| Group B | 32 |
Secondary outcomeCount of participants· From intravenous infusion of the drug up to 48 hours post-caesarean section
Number of Participants With Tranexamic Acid Side Effects
| Group | Value (Participants) |
|---|---|
| Group A | 7 |
| Group B | 3 |
Secondary outcomeCount of participants· At caesarean section up to 48 hours post-caesarean section
Number of Participants Requiring Emergency Surgery for PPH
| Group | Value (Participants) |
|---|---|
| Group A | 0 |
| Group B | 2 |
Secondary outcomeMedian· From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier
Number of Days of Participants' Hospital Stay
| Group | Value (days) |
|---|---|
| Group A | 5 |
| Group B | 5 |
Secondary outcomeMean· 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 - Weight
| Group | Value (grams) | Spread |
|---|---|---|
| Group A | 3087.85 | 523.98 |
| Group B | 3109.98 | 513.13 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group AParticipants 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. Tranexamic Acid: 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. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section. | 0 / 224 | 0 / 224 | 7 / 224 |
| Group BParticipants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section. | 0 / 227 | 0 / 227 | 3 / 227 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- Not stated
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
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
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