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| ID | Type | Description | Link |
|---|---|---|---|
| D43TW009343 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.
This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group/Group A | Experimental | The study group will receive TXA 1g intravenously at the onset of skin incision. |
|
| Control group/Group B | Placebo Comparator | There is an equivalent volume of normal saline for the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage (PPH) | Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section. | Up to day 2 postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss Using Hemoglobin Values | Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values | Up to day 2 postpartum |
| Mean Blood Loss as Estimated by Obstetrician |
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Inclusion Criteria: Women undergoing elective or emergency caesarean section with:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chipo Gwanzura, MD | University of Zimbabwe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital) | Harare | Zimbabwe | ||||
| Sally Mugabe Central Hospital Maternity Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37106343 | Derived | Gwanzura C, Gavi S, Mangiza M, Moyo FV, Lohman MC, Nhemachena T, Chipato T. Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section. BMC Anesthesiol. 2023 Apr 27;23(1):142. doi: 10.1186/s12871-023-02098-w. |
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It is not yet known if there will be a plan to make individual patient data (IPD) available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group/Group A_(Tranexamic Acid) | The study group will receive TXA 1g intravenously at the onset of skin incision. Tranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section |
| FG001 | Control Group/Group B_(Placebo) | There is an equivalent volume of normal saline for the control group. Normal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group/Group A_(Tranexamic Acid) | The study group will receive TXA 1g intravenously at the onset of skin incision. Tranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section |
| BG001 | Control Group/Group B_(Placebo) |
| 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 Hemorrhage (PPH) | Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section. | Postpartum hemorrhage defined as having a blood loss greater than or equal to 1000 mL using change in hemoglobin values. In the clinical trial, some participants in both arms had missing data because they did not have their laboratory measurements for hemoglobin done. In Group A (93 participants) and in Group B (87 participants) had missing assessments for PPH. | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
1 week
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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 | Study Group/Group A_(Tranexamic Acid) | The study group will receive TXA 1g intravenously at the onset of skin incision. Tranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| 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 | Jan 16, 2021 | Dec 19, 2022 | 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 |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.
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| Normal saline placebo | Other | 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group |
|
Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
| 2 hours |
| Occurrence of Postpartum Shock | Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse. | Up to day 2 postpartum |
| Use of Supplementary Uterotonic(s) | Number of women requiring supplementary uterotonics | Up to day 2 postpartum |
| Postpartum Transfusion | Number of women given postpartum transfusion | Up to day 2 postpartum |
| Emergency Surgery for PPH | Number of participants who had emergency surgery for PPH including caesarean hysterectomies | Up to day 2 postpartum |
| Change in Peripartum Haemoglobin | Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values. | Up to day 2 postpartum |
| Number of Participants With a Decrease in Peripartum Hemoglobin | Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL | Up to day 2 postpartum |
| Change in Peripartum Haematocrit | Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum | Up to day 2 postpartum |
| Admission Into Intensive Care Unit | Number of participants transferred to intensive care unit | Up to day 2 postpartum |
| Death From Any Cause | Number of participants who died from any cause | Up to date of death or day 4 from admission |
| Blood Pressure Measurements | Blood pressure at 15, 30, 45, 60, and 120 min after delivery | Up to 2 hours after the caesarean section |
| Number of Mild Adverse Events | Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness | Up to 24 hours after administration |
| Number of Severe Adverse Events |
| Up to day 3 postpartum |
| Any Other Unexpected Adverse Event | Number of unexpected events during and after the adminstration of study drug and duration of observation | Up to day 3 postpartum |
| Length of Hospital Stay | Duration of hospital admission in days | Up to day 3 postpartum |
| Harare |
| Zimbabwe |
There is an equivalent volume of normal saline for the control group. Normal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Abnormal Placentation | Count of Participants | Participants |
|
| Anemia | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Fetal Macrosomia | Count of Participants | Participants |
|
| Gestational Age (Weeks) | Count of Participants | Participants |
|
| History of PPH | Count of Participants | Participants |
|
| HIV status | Count of Participants | Participants |
|
| Multiple Pregnancy | Count of Participants | Participants |
|
| Number of Previous Cesarean Sections | Count of Participants | Participants |
|
| Polyhydramnios | Count of Participants | Participants |
|
| Previous Surgery | Count of Participants | Participants |
|
| Uterine Fibroids | Count of Participants | Participants |
|
| OG001 | Control Group/Group B_(Placebo) | There is an equivalent volume of normal saline for the control group. Normal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group |
|
|
|
| Secondary | Blood Loss Using Hemoglobin Values | Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values | Average blood loss in mL calculated using laboratory hemoglobin values collected from participants before and after procedure. | Posted | Mean | Standard Deviation | mL | Up to day 2 postpartum |
|
|
|
| Secondary | Mean Blood Loss as Estimated by Obstetrician | Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery. | Missing data for some participants due to estimates not being done at the time of delivery. | Posted | Mean | Standard Deviation | mL | 2 hours |
|
|
|
| Secondary | Occurrence of Postpartum Shock | Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse. | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
|
|
| Secondary | Use of Supplementary Uterotonic(s) | Number of women requiring supplementary uterotonics | Missing information about additional uterotonics for some participants due to data entry issues after delivery. | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
|
|
| Secondary | Postpartum Transfusion | Number of women given postpartum transfusion | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
|
|
| Secondary | Emergency Surgery for PPH | Number of participants who had emergency surgery for PPH including caesarean hysterectomies | Missing information from some participants due to data entry issues. | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
|
|
| Secondary | Change in Peripartum Haemoglobin | Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values. | Missing values due to missing information if blood draws were not done within the required time frame. | Posted | Mean | Standard Deviation | g/dL | Up to day 2 postpartum |
|
|
|
| Secondary | Number of Participants With a Decrease in Peripartum Hemoglobin | Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL | Missing data a result of laboratory specimens not being collected at the expected time from participants | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
|
|
| Secondary | Change in Peripartum Haematocrit | Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum | Missing data due laboratory measurements not being done for some participants as samples were not taken within required time frame. | Posted | Mean | Standard Deviation | percent of hematocrit change | Up to day 2 postpartum |
|
|
|
| Secondary | Admission Into Intensive Care Unit | Number of participants transferred to intensive care unit | data entry error for missing participant data | Posted | Count of Participants | Participants | Up to day 2 postpartum |
|
|
|
| Secondary | Death From Any Cause | Number of participants who died from any cause | Posted | Count of Participants | Participants | Up to date of death or day 4 from admission |
|
|
|
| Secondary | Blood Pressure Measurements | Blood pressure at 15, 30, 45, 60, and 120 min after delivery | Some participants did not have their systolic and diastolic blood pressure measurements done (missing data) | Posted | Mean | Standard Deviation | mmHg | Up to 2 hours after the caesarean section |
|
|
|
| Secondary | Number of Mild Adverse Events | Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness | Posted | Count of Participants | Participants | Up to 24 hours after administration |
|
|
|
| Secondary | Number of Severe Adverse Events |
| Posted | Count of Participants | Participants | Up to day 3 postpartum |
|
|
|
| Secondary | Any Other Unexpected Adverse Event | Number of unexpected events during and after the adminstration of study drug and duration of observation | Posted | Count of Participants | Participants | Up to day 3 postpartum |
|
|
|
| Secondary | Length of Hospital Stay | Duration of hospital admission in days | Missing data due to data entry errors | Posted | Mean | Standard Deviation | days | Up to day 3 postpartum |
|
|
|
| 0 |
| 611 |
| 0 |
| 611 |
| 50 |
| 611 |
| EG001 | Control Group/Group B_(Placebo) | There is an equivalent volume of normal saline for the control group. Normal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group | 0 | 613 | 1 | 613 | 48 | 613 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| between 26-35 years |
|
| greater than 35 years |
|
| Missing |
|
| 39 Weeks |
|
| 40 Weeks |
|
| 41 Weeks |
|
| 42+ Weeks |
|
| Missing |
|
| Unknown |
|
| Two |
|
| Three |
|
| Four |
|
| diastolic blood pressure 15 minutes after delivery |
|
|
| systolic blood pressure 30 minutes after delivery |
|
|
| diastolic blood pressure 30 minutes after delivery |
|
|
| systolic blood pressure 45 minutes after delivery |
|
|
| diastolic blood pressure 45 minutes after delivery |
|
|
| systolic blood pressure 60 minutes after delivery |
|
|
| Vomiting |
|
| No Vomiting |
|
| Dizziness |
|
| No Dizziness |
|
| Pulmonary Embolism |
|
| No Pulmonary Embolism |
|
| Myocardial Infarction |
|
| No Myocardial Infarction |
|
| Seizures |
|
| No Seizures |
|
| Renal failure requiring dialysis |
|
| No Renal failure requiring dialysis |
|