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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group B | Active Comparator | Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postpartum Haemorrhage (PPH) | PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation | Up to 48 hours post-caesarean section |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Blood loss during caesarean section based on visual estimation and calculation. | At caesarean section |
| Amount of Blood Transfused | Requirement by participant of blood transfusion |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsungai Chipato, MBChB FRCOG | Professor of Obstetrics and Gynaecology | Study Chair |
| Taazadza Nhemachena, MBChB MMED | Lecturer and Consultant | Study Chair |
| Chipo Gwanzura, MBChB | Registrar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harare Central Hospital | Harare | Zimbabwe | ||||
| Parirenyatwa Group of Hospitals |
It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors
TBA
Communicate with researcher on chipo.gwanzura@gmail.com
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From 8 April 2018 to 31 December 2018, we recruited 506 eligible patients. The trial was conducted at two tertiary institutions that are affiliated to the University of Zimbabwe. These serve as referral centres for 12 local authority clinics located in Harare as well as district and provincial hospitals in the surrounding provinces: Harare Central Hospital i.e. Harare Maternity Hospital (HMH) and Parirenyatwa Group of Hospitals i.e. Mbuya Nehanda Maternity Hospital (MNMH).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Group B | Participants 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Postpartum Haemorrhage (PPH) | PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation | Intention-to-treat population | Posted | Count of Participants | Participants | Up to 48 hours post-caesarean section |
|
Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section.
The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
The a priori power was not been achieved as the target sample size had not yet been achieved due to reasons beyond the scope of the study. The study had no placebo and was not blinded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Chipo Gwanzura | University of Zimbabwe | +263774718381 | chipo.gwanzura@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2019 | Oct 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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Trial is an open label randomized control trial
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|
|
| Oxytocin | Drug | 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section. |
|
|
| 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). | 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 | 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 | 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. | 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 | 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). | 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 | 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) | 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 | 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 | 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 |
| Harare |
| Zimbabwe |
| Protocol Violation |
|
| Had a vaginal delivery prior to caesarean delivery |
|
| Had emergency caesarean delivery prior to elective caesarean delivery |
|
| BG001 | Group B | Participants 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Median | Inter-Quartile Range | Weeks |
|
| HIV status | Count of Participants | Participants |
|
| Multiple pregnancy | Count of Participants | Participants |
|
| Placenta praevia | Count of Participants | Participants |
|
| Uterine fibroids | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Number of previous caesarean sections | Count of Participants | Participants |
|
| Previous surgery | Count of Participants | Participants |
|
| Anaemia (Hb < 11 g/dl) | Count of Participants | Participants |
|
| Foetal macrosomia (birth weight > 4000g) | Count of Participants | Participants |
|
| Breech presentation | Count of Participants | Participants |
|
| Risk assessment for PPH | Count of Participants | Participants |
|
| Type of anaesthesia | Count of Participants | Participants |
|
| OG001 | Group B | Participants 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. |
|
|
|
| Secondary | Estimated Blood Loss | Blood loss during caesarean section based on visual estimation and calculation. | Intention-to-treat population | Posted | Mean | Standard Deviation | ml | At caesarean section |
|
|
|
|
| Secondary | Amount of Blood Transfused | Requirement by participant of blood transfusion | Intention-to-treat population | Posted | Median | Inter-Quartile Range | units of blood given | At caesarean section up to 48 hours post-caesarean section |
|
|
|
|
| Secondary | Number of Participants With Use of Additional Uterotonics | Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol). | Intention-to-treat analysis | Posted | Count of Participants | Participants | At caesarean section up to 48 hours post-caesarean section |
|
|
|
|
| Secondary | Number of Participants With Tranexamic Acid Side Effects | Number of participants with adverse effects related to tranexamic acid use | Intention-to-treat population | Posted | Count of Participants | Participants | From intravenous infusion of the drug up to 48 hours post-caesarean section |
|
|
|
| Secondary | Number of Participants Requiring Emergency Surgery for PPH | Number of participants requiring emergency surgical procedures to manage any PPH that occurs | Intention-to-treat analysis | Posted | Count of Participants | Participants | At caesarean section up to 48 hours post-caesarean section |
|
|
|
| Secondary | 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. | Intention-to-treat population | Posted | Median | Inter-Quartile Range | days | From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier |
|
|
|
| Secondary | Neonatal Outcome - Weight | Neonatal birth weight in grams | Intention-to-treat population | Posted | Mean | Standard Deviation | grams | 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 |
|
|
|
| Secondary | 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). | Intention-to-treat analysis | Posted | Median | Inter-Quartile Range | units on a scale up to 10 | Scores at 1 minute from time of delivery and at 5 minutes after delivery |
|
|
|
| Secondary | 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 | Intention-to-treat population | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Neonatal Outcome - Number of Neonates Diagnosed With Jaundice | Number of neonates with clinical jaundice (yellowing of the skin or whites of the eyes) | Intention-to-treat population | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Neonatal Outcome - Thromboembolic Event | Number of neonatal thromboembolic events | Intention-to-treat population | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Neonatal Outcome - Death | Neonatal death that occurs | Intention-to-treat population | Posted | Count of Participants | Participants | 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 |
|
|
|
| 0 |
| 224 |
| 0 |
| 224 |
| 7 |
| 224 |
| EG001 | Group B | Participants 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 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010909 |
| Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Haemoglobin-based calculation of estimated blood loss |
|
| 0.968 |
0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968 |
| Superiority |
| t-test, 2 sided | 0.447 | Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447 | Superiority |