Rule of THUMB: A Multi-centre Cluster Trial Evaluating the Implementation of a Perioperative Care Complex Intervention to Improve Outcomes From Haemorrhage During and After Caesarean Section in African Hospitals
Phase: NA
Conditions: Postpartum Hemorrhage
Sponsor: Bruce Biccard

 
 
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The Rule of THUMB trial 
 
 
Multi-centre cluster trial evaluating the implementation of a perioperative care complex 
intervention to improve outcomes following haemorrhage during and after caesarean section in 
eight hospitals in four countries (Ethiopia, South Africa, Tanzania, and Uganda). 
 
Study 
 
To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention 
increases risk assessment and improves, diagnosis and compliance with proven interventions for 
haemorrhage during and after caesarean section. A mixed-methods process evaluation of the trial 
intervention. 
 
Statistical Analysis Plan (SAP) 
 
Version 1.0 
Date: 20/10/2025 
 
Registration ClinicalTrials.gov – NCT07005349 
Based on “Rule of THUMB protocol version 1.0 HREC approved” 
 
Persons contributing to the analysis plan 
Names and positions 
Professor Bruce Biccard, UCT 
Marcelle Crowther, UCT 
Rupert Pearse, QMUL 
David Bishop: UKZA 
Salome Maswime: UCT  
Fred Bulamba: BU 

 
 
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Godrey Barabona: KU 
Brook Demissie: AAU 
Robert Dyer: UCT  
Tim Stephens: QMUL 
Gwen Arendse (Statistician), UCT 
Authorisation 
Position 
Chief Investigator 
Name 
Marcelle Crowther 
Signature 
 
Date 
8 April 2026 
Position 
Trial Statistician 
Name 
Gwen Arendse 
Signature 
Date 
8 April 2026 
 
Remit of the SAP 
The purpose of this document is to provide details of the statistical analyses and presentation of 
results to be reported within the paper of the THUMB study documenting the perioperative 
interventions to improve outcomes related to haemorrhage before and after caesarean section in 
African hospitals. It is important to set these out and to agree them in advance of inspecting the 
outcome data for the study, so that data derived decisions in the analysis are avoided. Any 
exploratory, post hoc, or unplanned analysis will be clearly identified as such in the statistical 
analysis report. 
 
Timing of the SAP 
The SAP version 1.0 was written prior to analysis and prior to those writing the SAP having access to 
the trial data. 
 
 
 

 
 
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1. Study Summary 
Short title 
Rule of THUMB 
Methodology 
A multi-centre cluster trial. 
Research sites 
Maternity units in eight  hospitals in four countries (Ethiopia, South Africa, 
Tanzania, and Uganda).  
Primary objective 
and outcomes 
To evaluate whether implementation of the ‘Rule of THUMB’ perioperative 
complex intervention increases the number of risk assessment and improves, 
diagnosis and compliance with proven interventions for haemorrhage during 
and after caesarean section, by evaluating the following: 
1. Number of patients assessed as high-risk for postpartum haemorrhage 
2. Number of patients with administration of uterotonics intra- or 
postoperatively 
3. Number of patients with administration of tranexamic acid intra- or 
postoperatively 
4. Number of patients with uterine massage intra- or postoperatively after 
delivery of the baby 
5. Number of high-risk patients who received a postoperative clinician visit 
within four hours of discharge to the ward 
Secondary 
objective and 
outcomes 
To evaluate the effect of the trial intervention on the following patient 
outcomes: 
1. The number of patients with a diagnosis of postpartum haemorrhage 
2. 30 day in-hospital mortality 
3. Number of patients with a repeat laparotomy for suspected haemorrhage 
4. Duration of hospital stay 
5. The number of patients referred to higher level of care for further 
management of bleeding/resuscitation 
Number of 
patients 
Amongst the four participating countries, eight hospitals were included in the 
study. We intended to sample approximately 800 caesarean sections for the 
control data collection period, and 800 caesarean sections for the transition 
period, and 800 for the implementation period. Total data set is expected to 
include approximately 2400 patients (800 in the control period, 800 in the 
transition period and 800 in the implementation period). 

 
 
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Inclusion criteria 
Hospitals: Hospitals in participating countries that have an established 
maternity service that routinely perform caesarean section. 
Patients: Any female patient who requires a caesarean section. 
Exclusion criteria 
Hospitals: Hospitals that do not consent to be part of the trial; hospitals that 
do not run a 24-hour caesarean section theatre service. 
Patients: Patients who opt out of the trial will be excluded. 
Trial design 
Patients in the control phase received the current standard postoperative 
care at their hospital. The intervention (a quality improvement programme) 
was then implemented by the unit for all patients, aimed at delivering care 
that is already known to be effective in delivering better patient outcomes. 
This included a transition period, which was then followed by the 
implementation period. All patients were part of the quality improvement 
programme, but they were allowed to opt out of data collection. 
Patient follow-up 
Until hospital discharge or 30 days from surgery, whichever occurs first 
Data collection 
duration 
The duration of the entire study was six months from beginning of the control 
period to the end of the implementation period. All patients were followed 
until hospital discharge or censored at 30 days 
Proposed start 
date 
June 2025 
Proposed end date 
June 2026 
 
 
 

 
 
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2. Introduction 
Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occurs in 
low- and middle-income countries.1 A systematic review of studies between 1990 and 2017 reported 
that women in low- and middle-income countries who had a caesarean section were more likely to 
die, and one third died from postpartum haemorrhage.2 Evidence from the recent African Surgical 
Outcomes Study (ASOS) shows that caesarean section is associated with maternal deaths in Africa, 
with postpartum haemorrhage contributing up to 25% of cases. Maternal mortality following 
caesarean section in this African study was 50 times higher than in high-income countries, and 
mostly driven by peripartum haemorrhage and anaesthesia complications.3 In 2014, a World Health 
Organisation survey on global maternal deaths highlighted caesarean section as one of the key 
factors associated with the diagnosis of postpartum haemorrhage.4 
Few complex interventions for perioperative maternal haemorrhage have been tested in caesarean 
section, and many studies have not given due attention to processes of care, which may have a 
significant impact on outcomes in low- and middle-income countries. Despite the progress in 
postpartum haemorrhage research in these areas, there remains an important gap in the clinical 
evidence to define optimal care for patients at high risk of postpartum haemorrhage following 
caesarean section. Recent studies have examined a combination of interventions consisting of 
checklists, care bundles, or interlinked complex interventions. These interventions, mainly tested in 
patients having vaginal delivery or low-risk caesarean section, have shown positive results in 
reducing the incidence of complications and deaths due to postpartum haemorrhage.5 A Delphi 
consensus study in 2022 found that many health professionals recommended a surgical safety 
checklist and routine risk assessment.6 
The E-MOTIVE trial (a cluster randomised trial) showed that early detection of blood loss by 
objective measurement, combined with bundled care, improved patient outcomes following 
postpartum haemorrhage.5 The intervention was developed through a robust process that outlined a 
“first response to postpartum haemorrhage” bundle, and a “response to refractory postpartum 
haemorrhage” bundle.7 The E-MOTIVE trial showed improvement in the primary postpartum 
haemorrhage outcomes (a composite of severe postpartum haemorrhage, laparotomy, and death), 
in four sub-Saharan African countries. However, this trial included only patients who had undergone 
vaginal delivery, who were thought to represent a lower risk group than those undergoing caesarean 
section. 
Anders et al reported a multi-stage intervention to prevent deaths from postpartum haemorrhage in 
Niger over a period of 72 months.8 The intervention included prevention of postpartum 
haemorrhage, followed by staged treatment with misoprostol, intrauterine condom balloon 
tamponade and the use of non-inflatable anti-shock garment. Importantly, the intervention was 
based on a strong foundation of health care support with training and distribution of supplies, which 
are known to contribute to improvement in care. This reduced the rate of postpartum haemorrhage 
from 32% to 10% over a period of five years (2015 to 2020). It provided evidence that staged-care 
strategies can improve outcomes if based on a strong health care system that is equipped with 
resources and a trained workforce. Main et al suggested an “obstetric haemorrhage safety bundle” 
to standardise the multidisciplinary care for postpartum haemorrhage, through a consensus 

 
 
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statement.9 This bundle provides a framework for improved care of peri- caesarean section 
haemorrhage. 
We developed a complex intervention to improve maternal outcomes for patients undergoing 
caesarean section based on early diagnosis of haemorrhage during and after surgery coupled to 
early treatment through first-responder protocolised treatment using a care bundle of five elements 
called the rule of THUMB. The intervention is essentially a quality improvement programme aimed 
at delivering better care, care that is already known to be effective in delivering better patient 
outcomes. 
2.1 Aim 
To assess whether there is an improvement in haemorrhage outcomes before and after 
implementation of a perioperative care bundle package during a multi-centre cluster trial.  
2.2.1 Primary objectives 
To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention 
increases the number of risk assessment, and improves diagnosis and compliance with proven 
interventions for haemorrhage during and after caesarean section. 
2.2.2 Secondary objectives 
To evaluate the effect of the trial intervention on patient outcomes relevant to future trials. 
2.3.1 Cohort 
The cohort include any patient who requires a caesarean section. 
2.3.2 Outcomes 
2.3.2.1 Primary outcomes 
1. Number of patients assessed as high-risk for postpartum haemorrhage 
2. Number of patients with administration of uterotonics intra- or postoperatively 
3. Number of patients with administration of tranexamic acid intra- or postoperatively 
4. Number of patients with uterine massage intraoperatively after delivery, or postoperatively 
5. Number of high-risk patients with postoperative clinician visit within four hours of discharge to 
the ward 
2.3.2.2 Secondary outcomes 
1. Number of patients with diagnosis of postpartum haemorrhage 
2. 30-day in-hospital mortality 
3. Number of patients with a repeat laparotomy for suspected haemorrhage within 30 days 
4. Duration of hospital stay (censored at 30 days) 

 
 
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5. Number of patients with a referral to higher level of care for further management of 
bleeding/resuscitation within 30 days 
2.3.2.3 Baseline characteristics of the cohort 
Patient-specific covariates include: 
- 
Age 
- 
ASA status 
- 
Gravidity 
- 
Parity 
- 
Height (cm) 
- 
Weight (kg) 
- 
Body mass index (derived from height and weight) 
- 
Preoperative haemoglobin 
- 
Preoperative platelet count 
- 
Emergency or elective caesarean section  
- 
Anaesthesia provider 
- 
Obstetric provider 
- 
Type of Anaesthesia 
- 
Administration of vasopressor 
- 
Systolic blood pressure 
- 
Duration of caesarean section 
- 
Estimated blood loss 
- 
Monitoring in recovery 
- 
Recovery needs  
Hospital-specific covariates include:  
- 
Hospital level  
- 
Number of hospital beds 
- 
Number of theatres 
- 
Number of critical care beds 
- 
Number of high care beds 
- 
Dedicated caesarean section theatre 
- 
Overall number of caesarean sections per month 
- 
Number of elective caesarean sections per month 
- 
Number of emergency caesarean sections per month 
- 
24-hour staffed emergency theatre 
- 
Regular education training for staff 
- 
Simulation training for treatment of PPH 
- 
Protocols in place to prevent and treat PPH 
- 
Protocols to refer women to higher level of care 
- 
Ambulance transport to and from centres 
- 
Preoperative risk assessment for PPH 
- 
Critical incident reviews of PPH cases (>1,5L blood loss) 
- 
WHO surgical checklist perioperatively 

 
 
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- 
Details about the reimbursement status of the hospital. 
2.3.3 Definitions 
2.3.3.1 Definitions for patient level Primary outcomes 
Patient assessment of risk for postpartum haemorrhage (yes/no - binary): Risk assessment 
performed using a preoperative PPH risk assessment tool in the control period and the mandated 
risk assessment tool in the transition and implementation periods, and the patient documented to 
have one or more risk factors prior to commencement of caesarean section. 
Administration of uterotonics intra- or postoperatively (yes/no - binary): Uterotonics were 
administered following delivery of the fetus in accordance with local policy. 
Administration of tranexamic acid intra- or postoperatively (yes/no - binary): Tranexamic acid was 
administered following a diagnosis of postpartum haemorrhage. 
Uterine massage intraoperatively after delivery, or postoperatively (yes/no - binary): Uterine 
massage following delivery of the fetus or diagnosis of postpartum haemorrhage in accordance with 
local policy.  
Postoperative clinician visit within four hours of discharge to the ward (yes/no - binary): A 
documented postoperative visit for high-risk patients by a clinician (designation of clinician as per 
local hospital capacity) within four hours of discharge to the ward.  
2.3.3.2 Definitions for secondary outcomes 
A diagnosis of postpartum haemorrhage (yes/no - binary): Postpartum haemorrhage following 
caesarean section is defined as blood loss of >500 mL. The diagnostic criteria for estimating that this 
threshold has been exceeded will be decided at each hospital during the co-design phase. 
Some of the options that may be considered are: soaking of swabs (e.g., ≥ 3 soaked tape swabs), 
suction bottle >500 ml blood, haemodynamic instability (low SBP/high HR) as diagnosed by direct 
observation of significant/rapid bleeding by the anaesthetist and obstetric surgeon. 
30 day in-hospital mortality (alive/dead - binary): Death in-hospital, measured within 30 days 
following caesarean section. The day of the caesarean section shall be Day 0. Patients discharged 
prior to Day 30 will be marked as ‘Alive’. 
Repeat laparotomy for suspected haemorrhage (yes/no - binary): Did the patient undergo a 
laparotomy to obtain surgical control of bleeding following caesarean section? 
Duration of hospital stay (censored at 30 days) (continuous count): How long did the patient stay in 
hospital following caesarean section? The day of the caesarean section will be defined as day 0.  
Higher level of care (yes/no - binary): whether women were referred to higher level of care for 
further management of bleeding/resuscitation. 
 

 
 
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3. Trial design 
Control data are collected at all hospitals over a two-week period (usual care period). Thereafter, all 
hospitals are trained for 2-6 weeks, as required, on the intervention (transition period): comprising 
two mandatory risk assessments (preoperatively in theatre and postoperatively prior to discharge 
from the recovery area) which are linked to hospital-specific responses. Assessments for bleeding 
occurs intraoperatively (through direct vision, haemodynamic changes and/or measurement of 
blood loss) and postoperatively (with the use of the rapid assessment tool). If bleeding was 
diagnosed at any point, the THUMB checklist is used to activate bundled care. On discharge from 
recovery, high-risk patients are scheduled to receive a postoperative ward visit within four hours, 
where a further assessment for bleeding occurs. 
The initial intervention is modified in accordance with data collected during the usual care period. 
This initial intervention is then used in the transition period. Further intervention refinement occurs 
after the transition period of data recruitment and will be used in the implementation period. All 
clusters did not have to commence this process on the same date. 
 
4. Statistical Analysis Plan 
4.1 Recruitment / Sample size 
This is an international trial in four African countries. We included consecutive patients admitted to 
eight participating hospitals and undergoing caesarean section. The basis for participation in this trial 
was opt out i.e., patients were included unless they asked not to be included. All adult patients 
undergoing caesarean section were eligible for inclusion in the trial.  
For the eight hospitals, the expected delivery rate per month is between 500 – 1000. Given an 
average caesarean section rate of 30%, this will yield 150-300 caesarean sections per month, or 75-
150 caesarean sections per two-week period. We therefore expect approximately 100 caesarean 
sections per hospital per two-week period. This will result in 800 caesarean sections for the control 
data collection period, and 800 caesarean sections for the transition period, and 800 for the 
implementation period. Total data set is expected to include approximately 2400 patients (800 in the 
control period, 800 in the transition period and 800 in the implementation period). 
One-level clustering by hospital has been assumed, not accounting for clustering by countries 
separately. As no intra-cluster correlation (ICC) estimates are available, the resulting power for a 
range of ICCs is calculated. An ICC in the 0.01-0.1 range seems most likely. 
All sample size calculations are for a one-sample proportion tests, testing against a fixed value and 
accounting for clustering. The fixed values are based on baseline estimates, however, choosing 
target values might be preferable. System optimisation step rates assumed not used in analyses. 
Participation in the study, and completeness of follow-up will be illustrated by a STROBE flow 
diagram. 
Patient recruitment and description will be presented as follows:  

 
 
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- 
STROBE flow diagram including i) countries, ii) number of eligible patients, iii) patients 
included and excluded. 
- 
The number of participating hospitals, hospital characteristics and patients at each hospital 
level will be reported in a table. Detailed hospital characteristics will be provided in a 
Supplementary Table. 
- 
The patient characteristics of the cohort will be presented in the table. 
 
4.2 Analysis 
Outcomes will be presented for the whole cohort. Categorical variables will be described as the 
number (n/N) and proportions and will be compared using chi-square tests. We will describe 
continuous variables as either mean and standard deviation or median and inter-quartile range (IQR) 
based on the data distribution.  Comparisons of continuous variables between groups will be 
performed using t-tests, one-way ANOVA or equivalent non-parametric tests as appropriate. 
Basic statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS) 
version 28.0.1.1 (SPSS Inc., Chicago, IL, USA) and R statistical software: A language and environment 
for statistical computing. Vienna, Austria: R Foundation for Statistical Computing (2024) using Studio: 
Integrated Development Environment for R. Boston, MA: RStudio, Inc. (2024).  
4.2.1 Tables 
Table 1. Patient characteristics 
 
All patient 
(n=?) 
Control 
period 
(n=?) 
Transition 
period (n=?) 
Implementation 
period (n=?) 
P-value 
Age (mean 
(SD)/median (IQR)) 
 
 
 
 
 
ASA status 
- 
I 
- 
II 
- 
II 
- 
IV 
- 
V 
 
 
 
 
 
Gravidity (mean 
(SD)/median (IQR)) 
 
 
 
 
 
Parity (mean 
(SD)/median (IQR)) 
 
 
 
 
 
Height (mean 
(SD)/median (IQR)) 
 
 
 
 
 
Weight (mean 
(SD)/median (IQR)) 
 
 
 
 
 

 
 
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BMI (mean 
(SD)/median (IQR)) 
 
 
 
 
 
Preoperative Hb 
(mean (SD)/median 
(IQR)) 
 
 
 
 
 
Preoperative platelet 
count (mean 
(SD)/median (IQR)) 
 
 
 
 
 
Urgency of caesarean 
section 
- 
Emergency  
- 
Elective 
 
 
 
 
 
Anaesthesia provider 
- 
Non-specialist 
- 
Specialist 
- 
Non- doctor 
 
 
 
 
 
Obstetric provider 
- 
Non-specialist 
- 
Specialist 
- 
Non- doctor 
 
 
 
 
 
Type of anaesthesia 
- 
General  
- 
Spinal 
- 
Epidural 
- 
Sedation 
 
 
 
 
 
Vasopressor 
administered 
- 
Phenylephrine 
Ephedrine 
- 
Adrenaline or 
noradrenaline 
- 
Other 
- 
None 
 
 
 
 
 
Systolic blood 
pressure ≤ 80 mmHg 
(mean (SD)/median 
(IQR)) 
 
 
 
 
 

 
 
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Caesarean section 
duration (mean 
(SD)/median (IQR)) 
 
 
 
 
 
Estimated blood loss 
(mean (SD)/median 
(IQR)) 
 
 
 
 
 
Monitoring in 
recovery 
- 
Heart rate 
- 
Blood 
pressure 
- 
Saturation 
- 
Respiratory 
rate 
- 
Bleeding 
- 
Spinal level 
 
 
 
 
 
Recovery needs 
- 
Vasopressors 
needed in 
recovery 
- 
Oxygen 
dependent in 
recovery 
- 
Rapid 
assessment 
tool used 
 
 
 
 
 
 
Table S1: Hospital characteristics 
 
Resources and activities  
Hospital level 
- 
Primary 
- 
Secondary 
- 
Tertiary 
 
Number of hospital beds (mean (SD)/median (IQR)) 
 
Number of theatres (mean (SD)/median (IQR)) 
 
Number of critical care beds (mean (SD)/median 
(IQR)) 
 
Number of high care beds (mean (SD)/median (IQR)) 
 

 
 
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Dedicated caesarean section theatre 
- 
Yes 
- 
No 
 
Total number of caesarean sections per month 
(mean (SD)/median (IQR)) 
 
Number of elective caesarean sections per month 
(mean (SD)/median (IQR)) 
 
Number of emergency caesarean sections per month 
(mean (SD)/median (IQR)) 
 
24 hour staffed emergency theatre 
- 
Yes 
- 
No 
 
Regular education training for staff 
- 
Yes 
- 
No 
 
Simulation training for treatment of PPH 
- 
Yes 
- 
No 
 
Protocols for prevention and treatment for PPH 
- 
Yes 
- 
No 
 
Protocols to refer women to higher level of care 
- 
Yes 
- 
No 
 
Ambulance transport to and from centres 
- 
Yes 
- 
No 
 
Preoperative risk assessment for PPH 
- 
Yes 
- 
No 
 
Critical incident reviews of PPH cases (>1,5L blood 
loss) 
- 
Yes 
- 
No 
 

 
 
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WHO surgical checklist perioperatively 
- 
Yes 
- 
No 
 
Details of reimbursement status of the hospital 
- 
Government 
- 
Private 
- 
Non-profit 
 
 
Table 2: Primary and secondary outcome characteristics 
 
All patients (n=?) 
Control period 
(n=?) 
Implementation 
period (n=?) 
P-value 
Primary 
outcomes 
 
 
 
 
Identified as 
high risk for 
PPH 
- 
Yes 
- 
No 
 
 
 
 
Uterotonics 
administered 
- 
Yes 
- 
No 
 
 
 
 
 
Tranexamic 
acid given 
- 
Yes 
- 
No 
 
 
 
 
Uterine 
massage 
performed 
- 
Yes 
- 
No 
 
 
 
 
Postoperative 
visit done 
- 
Yes 
- 
No 
 
 
 
 
Secondary 
outcomes 
 
 
 
 
Postpartum 
haemorrhage 
diagnosed 
- 
Yes 
- 
No 
 
 
 
 

 
 
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30-day in-
hospital 
mortality 
- 
Dead 
- 
Alive 
 
 
 
 
Repeat 
laparotomy 
- 
Yes 
- 
No 
 
 
 
 
Duration of 
hospital stay 
(mean 
(SD)/median 
(IQR)) 
 
 
 
 
Referral to 
higher level of 
care 
- 
Yes 
- 
No 
 
 
 
 

 
 
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Table S2: Patient characteristics stratified by country 
 
All 
patients 
(n=?) 
Country 1 
(n=?) 
Country 2 
(n=?) 
Country 3 
(n=?) 
Country 4 
(n=?) 
P-value 
Age (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
ASA status 
- 
I 
- 
II 
- 
II 
- 
IV 
- 
V 
 
 
 
 
 
 
Gravidity (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
Parity (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
Height (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
Weight (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
BMI (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
Preoperative Hb 
(mean (SD)/median 
(IQR)) 
 
 
 
 
 
 
Preoperative platelet 
count (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
Urgency of caesarean 
section 
- 
Emergency  
- 
Elective 
 
 
 
 
 
 
Anaesthesia provider 
- 
Non-specialist 
- 
Specialist 
- 
Non- doctor 
 
 
 
 
 
 

 
 
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Obstetric provider 
- 
Non-specialist 
- 
Specialist 
- 
Non- doctor 
 
 
 
 
 
 
Type of anaesthesia 
- 
General  
- 
Spinal 
- 
Epidural 
- 
Sedation 
 
 
 
 
 
 
Vasopressor 
administered 
- 
Phenylephrine 
Ephedrine 
- 
Adrenaline or 
noradrenaline 
- 
Other 
- 
None 
 
 
 
 
 
 
Systolic blood 
pressure ≤ 80 mmHg 
(mean (SD)/median 
(IQR)) 
 
 
 
 
 
 
Caesarean section 
duration (mean 
(SD)/median (IQR)) 
 
 
 
 
 
 
Estimated blood loss 
(mean (SD)/median 
(IQR)) 
 
 
 
 
 
 
Monitoring in 
recovery 
- 
Heart rate 
- 
Blood 
pressure 
- 
Saturation 
- 
Respiratory 
rate 
- 
Bleeding 
- 
Spinal level 
 
 
 
 
 
 
Recovery needs 
- 
Vasopressors 
needed in 
recovery 
 
 
 
 
 
 

 
 
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- 
Oxygen 
dependent in 
recovery 
- 
Rapid 
assessment 
tool used 
 
 Table 3: Characteristics of patients with a peripartum or postpartum haemorrhage 
 
Intraoperative 
(n=?) 
Postoperative 
recovery (n=?) 
Postoperative 
ward (n=?) 
P-value 
Cause of bleeding 
- 
Tone 
- 
Tissue 
- 
Thrombin 
- 
Trauma 
 
 
 
 
Abnormal placentation 
at caesarean section 
- 
Yes 
- 
No 
 
 
 
 
Relook laparotomy 
- 
Yes 
- 
No 
 
 
 
 
Uterine trauma  
- 
B-Lynch 
- 
Artery ligations 
- 
Hysterectomy 
- 
Tear repaired 
- 
Balloon 
tamponade 
- 
Haemostatic 
sutures 
 
 
 
 
Transfusion required 
- 
Yes 
- 
No 
 
 
 
 
Haemoglobin 
measurement (mean 
(SD)/median (IQR)) 
 
 
 
 
Colloid given 
- 
Yes 
 
 
 
 

 
 
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- 
No  
- 
Not available 
Temperature <35.5° C 
- 
Yes 
- 
No 
- 
Not done 
 
 
 
 
Called for help 
- 
Yes 
- 
No 
 
 
 
 
Uterine massage 
performed 
- 
Yes 
- 
No 
 
 
 
 
Uterotonics given 
- 
≥1 
- 
Long acting 
- 
≥2 boluses 
 
 
 
 
Monitoring considered 
- 
Yes 
- 
No 
 
 
 
 
Bedside visit  
- 
Yes 
- 
No 
 
 
 
 
5. References 
1. World_Health_Organization. Trends in maternal mortality 2000 to 2020: estimates by WHO, 
UNICEF, UNFPA, World Bank Group and UNDESA/Population Division. Geneva: World Health Organi-
zation2023.  
2. Sobhy S, Arroyo-Manzano D, Murugesu N, Karthikeyan G, et al. Maternal and perinatal mortality 
and complications associated with caesarean section in low-income and middle-income countries: a 
systematic review and meta-analysis. Lancet. 2019;393(10184):1973-82. 
https://doi.org/:10.1016/S0140-6736(18)32386-9  
3. Bishop D, Dyer RA, Maswime S, Rodseth RN, et al. Maternal and neonatal outcomes after caesar-
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4. Sheldon WR, Blum J, Vogel JP, Souza JP, et al. Postpartum haemorrhage management, risks, and 
maternal outcomes: findings from the World Health Organization Multicountry Survey on Maternal 
and Newborn Health. BJOG. 2014;121 Suppl 1:5-13. https://doi.org/:10.1111/1471-0528.12636  

 
 
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5. Gallos I, Devall A, Martin J, Middleton L, et al. Randomized Trial of Early Detection and Treatment 
of Postpartum Hemorrhage. N Engl J Med. 2023;389(1):11-21. 
https://doi.org/:10.1056/NEJMoa2303966  
6. Group ACDH. Identifying interventions to reduce peripartum haemorrhage associated with caesar-
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https://doi.org/:10.1371/journal.pgph.0000455  
7. Althabe F, Therrien MNS, Pingray V, Hermida J, et al. Postpartum hemorrhage care bundles to im-
prove adherence to guidelines: A WHO technical consultation. Int J Gynaecol Obstet. 
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8. Seim AR, Alassoum Z, Souley I, Bronzan R, Mounkaila A, Ahmed LA. The effects of a peripartum 
strategy to prevent and treat primary postpartum haemorrhage at health facilities in Niger: a longi-
tudinal, 72-month study. Lancet Glob Health. 2023;11(2):e287-e95. https://doi.org/:10.1016/S2214-
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