THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage

NCT07005349 | Recruiting

• 1 other identifier: The Rule of THUMB trial
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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. 1.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.
2. 2.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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (5)

• Patient assessed as high-risk for postpartum haemorrhage

  To evaluate the effect of the trial intervention on identification of high-risk patients

  6 months

• Administration of uterotonics intra- or postoperatively

  To evaluate the effect of the trial intervention on administration of uterotonics

  6 months

• Administration of tranexamic acid intra- or postoperatively

  To evaluate the effect of the trial intervention on administration of tranexamic acid

  6 months

• Uterine massage intra- or postoperatively after delivery of the baby

  To evaluate the effect of the trial intervention on uterine massage

  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

  6 months

Secondary Outcomes (5)

• Diagnosis of postpartum haemorrhage

  6 months

• 30 day in-hospital mortality

  6 months

• Repeat laparotomy for suspected haemorrhage

  6 months

• Duration of hospital stay

  6 months

• Referral to higher level of care for further management of bleeding/resuscitation

  6 months

Study Arms (2)

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.

Other: Quality improvement program

Interventions

Quality improvement program OTHER

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.

Intervention

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who requires a caesarean section in participating countries with hospitals that routinely perform caesarean section.

You may not qualify if:

• Patients who opt out of the trial will be excluded.

Sponsors & Collaborators

• Bruce Biccard: lead

Study Sites (1)

Mowbray Maternity Hospital

Cape Town, South Africa

RECRUITING

Related Publications (8)

• 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.

  PMID: 30929893 RESULT

• Bishop 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.

  PMID: 30879511 RESULT

• Sheldon 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.

  PMID: 24641530 RESULT

• Gallos 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.

  PMID: 37158447 RESULT

• APORG 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.

  PMID: 36962699 RESULT

• Althabe 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.

  PMID: 31709527 RESULT

• 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 longitudinal, 72-month study. Lancet Glob Health. 2023 Feb;11(2):e287-e295. doi: 10.1016/S2214-109X(22)00518-6.

  PMID: 36669809 RESULT

• Main 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.

  PMID: 26091046 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BRUCE BICCARD, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARGOT FLINT, PhD

CONTACT

00274045001; margot.flint@uct.ac.za

BRUCE BICCARD, PhD

CONTACT

00274045015; bruce.biccard@uct.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication of the results, IPD will be made available upon request.
• Access Criteria: Any researchers, and clinicians or healthcare workers continuing care of the participants after the study, as well as the participants themselves.

Locations

ZA (1)