Postpartum HemorrhageNCT07005349
THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage
A study testing Quality improvement program in people with Postpartum Hemorrhage, run by Bruce Biccard at 1 site in South Africa.
Trial summary
The quality improvement project evaluating the delivery of a perioperative care complex intervention to improve haemorrhage-related outcomes in patients undergoing caesarean section. The objectives of the current study will be: 1. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Quality improvement program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient who requires a caesarean section in participating countries with hospitals that routinely perform caesarean section.
Who cannot join
- Patients who opt out of the trial will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Mowbray Maternity Hospital
Cape Town
Margot Flint, PhD, 0721222111, margot.flint@uct.ac.za
About this study
Official title: 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
The quality improvement project evaluating the delivery of a perioperative care complex intervention to improve haemorrhage-related outcomes in patients undergoing caesarean section. The objectives of the current study will be:
- To evaluate whether implementation of the 'Rule of THUMB' perioperative complex intervention increases risk assessment, diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.
- To understand the influence of contextual and socio-dynamic factors on how the trial results were achieved and how the intervention mechanisms did, or did not, work in practice (the process evaluation). The findings from this study will be used subsequently to modify and improve the quality improvement intervention, so that it can be delivered at scale across Africa and assess its impact on haemorrhage during and after caesarean section in the future.
Read the detailed description
The study involves 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. The intervention comprises 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 will occur intraoperatively (through direct vision, haemodynamic changes and/or measurement of blood loss) and postoperatively (with the use of the rapid assessment tool). If bleeding is diagnosed at any point, the THUMB checklist will be used to activate bundled care. On discharge from recovery, high-risk patients will be scheduled to receive a postoperative ward visit within four hours, when a further assessment for bleeding will occur. Staff at each hospital will collect data for the two-week usual care (control) phase describing usual perioperative care. This will be followed by a period of co-design and training (2-6 weeks, as required), and then implementation of the intervention phase for a further two weeks at each hospital. The initial intervention will be modified in accordance with data collected during the usual care phase, in conjunction with local stakeholders. Further intervention refinement will occur after each period of data recruitment and analysis. Two intervention cycles will occur. 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. The intervention aims to improve compliance with recommended care for prevention and treatment of haemorrhage during and after caesarean section by creating a bundle of care that is delivered simultaneously (not sequentially) by first responders. It includes two mandated risk assessments before and after surgery, and implementation of the THUMB care bundle either in response to bleeding intraoperatively or in recovery or the ward through the rapid assessment tool.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Quality improvement program
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement programOther
The intervention comprises 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 will occur intraoperatively (through direct vision, haemodynamic changes and/or measurement of blood loss) and postoperatively (with the use of the rapid assessment tool). If bleeding is diagnosed at any point, the THUMB checklist will be used to activate bundled care. On discharge from recovery, high-risk patients will be scheduled to receive a postoperative ward visit within four hours, when a further assessment for bleeding will occur.
| Study group | Role | What they receive |
|---|---|---|
| Control phase | No intervention | Control data will be collected at all hospitals over a two-week period (usual care phase). Patients in the control phase will receive the current standard postoperative care. |
| Intervention | Active comparator | The intervention (a quality improvement programme) will then be implemented by the unit for all patients, aimed at delivering care that is already known to be effective in delivering better patient outcomes. Receives: Other: Quality improvement program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient assessed as high-risk for postpartum haemorrhage
To evaluate the effect of the trial intervention on identification of high-risk patients
Measured: 6 months
Administration of uterotonics intra- or postoperatively
To evaluate the effect of the trial intervention on administration of uterotonics
Measured: 6 months
Administration of tranexamic acid intra- or postoperatively
To evaluate the effect of the trial intervention on administration of tranexamic acid
Measured: 6 months
Uterine massage intra- or postoperatively after delivery of the baby
To evaluate the effect of the trial intervention on uterine massage
Measured: 6 months
A postoperative clinician visit within four hours of discharge to the ward
To evaluate the effect of the trial intervention on clinician ward visit postoperatively
Measured: 6 months
Secondary outcomes (5)
Diagnosis of postpartum haemorrhage
To evaluate the effect of the trial intervention on a diagnosis of postpartum haemorrhage
Measured: 6 months
30 day in-hospital mortality
To evaluate the effect of the trial intervention on 30 day in-hospital mortality
Measured: 6 months
Repeat laparotomy for suspected haemorrhage
To evaluate the effect of the trial intervention on repeat laparotomy for suspected haemorrhage
Measured: 6 months
Duration of hospital stay
To evaluate the effect of the trial intervention on duration of hospital stay
Measured: 6 months
Referral to higher level of care for further management of bleeding/resuscitation
To evaluate the effect of the trial intervention on referral to higher level of care for further management of bleeding/resuscitation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postpartum 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruce Biccard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruce Biccard, University of Cape Town
- Investigators
- BRUCE BICCARD, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005349
- Sponsor's protocol ID
- The Rule of THUMB trial
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with researchers upon request, including, the supporting information selected below.
Publications
Sobhy S, Arroyo-Manzano D, Murugesu N, Karthikeyan G, Kumar V, Kaur I, Fernandez E, Gundabattula SR, Betran AP, Khan K, Zamora J, Thangaratinam S. 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 May 11;393(10184):1973-1982. doi: 10.1016/S0140-6736(18)32386-9. Epub 2019 Mar 28.
PubMed 30929893Bishop D, Dyer RA, Maswime S, Rodseth RN, van Dyk D, Kluyts HL, Tumukunde JT, Madzimbamuto FD, Elkhogia AM, Ndonga AKN, Ngumi ZWW, Omigbodun AO, Amanor-Boadu SD, Zoumenou E, Basenero A, Munlemvo DM, Youssouf C, Ndayisaba G, Antwi-Kusi A, Gobin V, Forget P, Mbwele B, Ndasi H, Rakotoarison SR, Samateh AL, Mehyaoui R, Patel-Mujajati U, Sani CM, Esterhuizen TM, Madiba TE, Pearse RM, Biccard BM; ASOS investigators. Maternal and neonatal outcomes after caesarean delivery in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet Glob Health. 2019 Apr;7(4):e513-e522. doi: 10.1016/S2214-109X(19)30036-1.
PubMed 30879511Sheldon WR, Blum J, Vogel JP, Souza JP, Gulmezoglu AM, Winikoff B; WHO Multicountry Survey on Maternal and Newborn Health Research Network. Postpartum haemorrhage management, risks, and maternal outcomes: findings from the World Health Organization Multicountry Survey on Maternal and Newborn Health. BJOG. 2014 Mar;121(Suppl 1):5-13. doi: 10.1111/1471-0528.12636.
PubMed 24641530Gallos I, Devall A, Martin J, Middleton L, Beeson L, Galadanci H, Alwy Al-Beity F, Qureshi Z, Hofmeyr GJ, Moran N, Fawcus S, Sheikh L, Gwako G, Osoti A, Aswat A, Mammoliti KM, Sindhu KN, Podesek M, Horne I, Timms R, Yunas I, Okore J, Singata-Madliki M, Arends E, Wakili AA, Mwampashi A, Nausheen S, Muhammad S, Latthe P, Evans C, Akter S, Forbes G, Lissauer D, Meher S, Weeks A, Shennan A, Ammerdorffer A, Williams E, Roberts T, Widmer M, Oladapo OT, Lorencatto F, Bohren MA, Miller S, Althabe F, Gulmezoglu M, Smith JM, Hemming K, Coomarasamy A. Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage. N Engl J Med. 2023 Jul 6;389(1):11-21. doi: 10.1056/NEJMoa2303966. Epub 2023 May 9.
PubMed 37158447APORG Caesarean Delivery Haemorrhage Group. Identifying interventions to reduce peripartum haemorrhage associated with caesarean delivery in Africa: A Delphi consensus study. PLOS Glob Public Health. 2022 Aug 31;2(8):e0000455. doi: 10.1371/journal.pgph.0000455. eCollection 2022.
PubMed 36962699Althabe F, Therrien MNS, Pingray V, Hermida J, Gulmezoglu AM, Armbruster D, Singh N, Guha M, Garg LF, Souza JP, Smith JM, Winikoff B, Thapa K, Hebert E, Liljestrand J, Downe S, Garcia Elorrio E, Arulkumaran S, Byaruhanga EK, Lissauer DM, Oguttu M, Dumont A, Escobar MF, Fuchtner C, Lumbiganon P, Burke TF, Miller S. Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation. Int J Gynaecol Obstet. 2020 Mar;148(3):290-299. doi: 10.1002/ijgo.13028. Epub 2019 Dec 23.
PubMed 31709527Seim 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 longitudinal, 72-month study. Lancet Glob Health. 2023 Feb;11(2):e287-e295. doi: 10.1016/S2214-109X(22)00518-6.
PubMed 36669809Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869.
PubMed 26091046
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07005349
- Acronym / sponsor ID
- The Rule of THUMB trial
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Bruce BiccardUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The quality improvement project evaluating the delivery of a perioperative care complex intervention to improve haemorrhage-related outcomes in patients undergoing caesarean section. The objectives of the current study will be:
- To evaluate whether implementation of the 'Rule of THUMB' perioperative complex intervention increases risk assessment, diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.
- To understand the influence of contextual and socio-dynamic factors on how the trial results were achieved and how the intervention mechanisms did, or did not, work in practice (the process evaluation). The findings from this study will be used subsequently to modify and improve the quality improvement intervention, so that it can be delivered at scale across Africa and assess its impact on haemorrhage during and after caesarean section in the future.
Detailed description
The study involves 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. The intervention comprises 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 will occur intraoperatively (through direct vision, haemodynamic changes and/or measurement of blood loss) and postoperatively (with the use of the rapid assessment tool). If bleeding is diagnosed at any point, the THUMB checklist will be used to activate bundled care. On discharge from recovery, high-risk patients will be scheduled to receive a postoperative ward visit within four hours, when a further assessment for bleeding will occur. Staff at each hospital will collect data for the two-week usual care (control) phase describing usual perioperative care. This will be followed by a period of co-design and training (2-6 weeks, as required), and then implementation of the intervention phase for a further two weeks at each hospital. The initial intervention will be modified in accordance with data collected during the usual care phase, in conjunction with local stakeholders. Further intervention refinement will occur after each period of data recruitment and analysis. Two intervention cycles will occur. 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. The intervention aims to improve compliance with recommended care for prevention and treatment of haemorrhage during and after caesarean section by creating a bundle of care that is delivered simultaneously (not sequentially) by first responders. It includes two mandated risk assessments before and after surgery, and implementation of the THUMB care bundle either in response to bleeding intraoperatively or in recovery or the ward through the rapid assessment tool.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control phase | No intervention | –Control data will be collected at all hospitals over a two-week period (usual care phase). Patients in the control phase will receive the current standard postoperative care. |
| Intervention | Active comparator | Other: Quality improvement programThe intervention (a quality improvement programme) will then be implemented by the unit for all patients, aimed at delivering care that is already known to be effective in delivering better patient outcomes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who requires a caesarean section in participating countries with hospitals that routinely perform caesarean section.
Key exclusion criteria (1 listed)
- Patients who opt out of the trial will be excluded.
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 |
|---|---|---|
| Quality improvement programThe intervention comprises 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 will occur intraoperatively (through direct vision, haemodynamic changes and/or measurement of blood loss) and postoperatively (with the use of the rapid assessment tool). If bleeding is diagnosed at any point, the THUMB checklist will be used to activate bundled care. On discharge from recovery, high-risk patients will be scheduled to receive a postoperative ward visit within four hours, when a further assessment for bleeding will occur. | Other | Intervention |
Primary outcome
Patient assessed as high-risk for postpartum haemorrhage
Time frame: 6 months
To evaluate the effect of the trial intervention on identification of high-risk patients
Administration of uterotonics intra- or postoperatively
Time frame: 6 months
To evaluate the effect of the trial intervention on administration of uterotonics
Administration of tranexamic acid intra- or postoperatively
Time frame: 6 months
To evaluate the effect of the trial intervention on administration of tranexamic acid
Uterine massage intra- or postoperatively after delivery of the baby
Time frame: 6 months
To evaluate the effect of the trial intervention on uterine massage
A postoperative clinician visit within four hours of discharge to the ward
Time frame: 6 months
To evaluate the effect of the trial intervention on clinician ward visit postoperatively
5 secondary outcomes
Diagnosis of postpartum haemorrhage
Time frame: 6 months
30 day in-hospital mortality
Time frame: 6 months
Repeat laparotomy for suspected haemorrhage
Time frame: 6 months
Duration of hospital stay
Time frame: 6 months
Referral to higher level of care for further management of bleeding/resuscitation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 30929893Sobhy S, Arroyo-Manzano D, Murugesu N, Karthikeyan G, Kumar V, Kaur I, Fernandez E, Gundabattula SR, Betran AP, Khan K, Zamora J, Thangaratinam S. 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 May 11;393(10184):1973-1982. doi: 10.1016/S0140-6736(18)32386-9. Epub 2019 Mar 28.
- Results publication: PubMed 30879511Bishop D, Dyer RA, Maswime S, Rodseth RN, van Dyk D, Kluyts HL, Tumukunde JT, Madzimbamuto FD, Elkhogia AM, Ndonga AKN, Ngumi ZWW, Omigbodun AO, Amanor-Boadu SD, Zoumenou E, Basenero A, Munlemvo DM, Youssouf C, Ndayisaba G, Antwi-Kusi A, Gobin V, Forget P, Mbwele B, Ndasi H, Rakotoarison SR, Samateh AL, Mehyaoui R, Patel-Mujajati U, Sani CM, Esterhuizen TM, Madiba TE, Pearse RM, Biccard BM; ASOS investigators. Maternal and neonatal outcomes after caesarean delivery in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet Glob Health. 2019 Apr;7(4):e513-e522. doi: 10.1016/S2214-109X(19)30036-1.
- Results publication: PubMed 24641530Sheldon WR, Blum J, Vogel JP, Souza JP, Gulmezoglu AM, Winikoff B; WHO Multicountry Survey on Maternal and Newborn Health Research Network. Postpartum haemorrhage management, risks, and maternal outcomes: findings from the World Health Organization Multicountry Survey on Maternal and Newborn Health. BJOG. 2014 Mar;121(Suppl 1):5-13. doi: 10.1111/1471-0528.12636.
- Results publication: PubMed 37158447Gallos I, Devall A, Martin J, Middleton L, Beeson L, Galadanci H, Alwy Al-Beity F, Qureshi Z, Hofmeyr GJ, Moran N, Fawcus S, Sheikh L, Gwako G, Osoti A, Aswat A, Mammoliti KM, Sindhu KN, Podesek M, Horne I, Timms R, Yunas I, Okore J, Singata-Madliki M, Arends E, Wakili AA, Mwampashi A, Nausheen S, Muhammad S, Latthe P, Evans C, Akter S, Forbes G, Lissauer D, Meher S, Weeks A, Shennan A, Ammerdorffer A, Williams E, Roberts T, Widmer M, Oladapo OT, Lorencatto F, Bohren MA, Miller S, Althabe F, Gulmezoglu M, Smith JM, Hemming K, Coomarasamy A. Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage. N Engl J Med. 2023 Jul 6;389(1):11-21. doi: 10.1056/NEJMoa2303966. Epub 2023 May 9.
- Results publication: PubMed 36962699APORG Caesarean Delivery Haemorrhage Group. Identifying interventions to reduce peripartum haemorrhage associated with caesarean delivery in Africa: A Delphi consensus study. PLOS Glob Public Health. 2022 Aug 31;2(8):e0000455. doi: 10.1371/journal.pgph.0000455. eCollection 2022.
- Results publication: PubMed 31709527Althabe F, Therrien MNS, Pingray V, Hermida J, Gulmezoglu AM, Armbruster D, Singh N, Guha M, Garg LF, Souza JP, Smith JM, Winikoff B, Thapa K, Hebert E, Liljestrand J, Downe S, Garcia Elorrio E, Arulkumaran S, Byaruhanga EK, Lissauer DM, Oguttu M, Dumont A, Escobar MF, Fuchtner C, Lumbiganon P, Burke TF, Miller S. Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation. Int J Gynaecol Obstet. 2020 Mar;148(3):290-299. doi: 10.1002/ijgo.13028. Epub 2019 Dec 23.
- Results publication: PubMed 36669809Seim 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 longitudinal, 72-month study. Lancet Glob Health. 2023 Feb;11(2):e287-e295. doi: 10.1016/S2214-109X(22)00518-6.
- Results publication: PubMed 26091046Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869.
- Individual participant dataSharing planned: Yes. IPD will be shared with researchers upon request, including, the supporting information selected below.
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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.
BRUCE BICCARD, PhD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement program in people with Postpartum Hemorrhage, run by Bruce Biccard at 1 site in South Africa.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARGOT FLINT, PhD (00274045001, margot.flint@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient assessed as high-risk for postpartum haemorrhage (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07005349, which also lists 8 linked publications.
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 13 Apr 2026.