Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907769424884 Date of Approval: 01/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Uterine vacuum tamponade for treatment of postpartum haemorrhage: a randomized study
Official scientific title Uterine vacuum tamponade for treatment of postpartum haemorrhage: a randomized study
Brief summary describing the background and objectives of the trial Background WHO recommends Uterine Balloon tamponade (UBT) for the treatment of postpartum haemorrhage (PPH) unresponsive to uterotonics. One randomized trial has found increased bleeding and mortality with UBT plus misoprostol versus misoprostol alone . There is a compelling public health obligation to conduct further research to seek alternative effective PPH treatments. Uterine vacuum tamponade (UVT) is an alternative approach using negative intrauterine pressure to contract the uterus and reduce bleeding. Several rigid and flexible suction catheters with multiple apertures have been designed or adapted for use for uterine vacuum tamponade. Observational studies, have found an impressive association with prevention and arrest of PPH, but to date no randomized trials have been reported. A purpose-designed disposable uterine vacuum tamponade device (InPress) is under development. However, because of cost this may not be feasible for use in low-income settings. The PI has identified low-cost, widely available soft plastic catheters and performed a preliminary assessment of functionality of these catheters in 45 cases of caesarean section, with no complications. If effective, such catheters could be implemented on a wide scale globally due to low cost and availability. Overall aim of research program To evaluate the effectiveness of UVT for treatment of PPH Current Study Objectives To conduct a limited size, randomized pilot study of uterine vacuum tamponade for the treatment of PPH To assess the feasibility of a large, multicenter randomized trial of the effectiveness of uterine vacuum tamponade and uterine balloon tamponade for treatment of PPH, as discussed with WHO at a meeting in Geneva to plan the WHO trial on 23-24 January 2019. To advance local research capacity by involving junior researchers (consultants or medical officers/registrars) as trainee site PI’s under supervision/mentorship of an experienced local researcher.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) STUT study
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postpartum haemorrhage
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2019
Actual trial start date 10/01/2020
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 03/05/2024
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 59
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Suction tube uterine tamponade Single application Until bleeding controlled (< 24 hours) Uterine vacuum tamponade (UVT) using soft plastic suction catheter. If bleeding not controlled within 20 min (or sooner if clinically indicated), proceed to further management according to local standard of care protocols (these might include additional uterotonics, tranexamic acid, compression methods, uterine balloon tamponade or laparotomy). 42
Control Group Standard care N/A Until bleeding controlled (<24 hours) Care according to local protocols eg additional uterotonics, tranexamic acid, compression methods, uterine balloon tamponade or laparotomy. 42 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women 18 years old or more with PPH thought to be arising from the uterine cavity; condition not imminently life-threatening; no serious medical conditions. Other possible causes of haemorrhage such as cervical or vaginal tears will be excluded by inspection according to local care protocols prior to randomization Absence of inclusion criteria Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/05/2019 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
York Rd, Parktown JHB 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measured blood loss within 60 minutes after enrollment >median for the control group (lognormal distribution comparison), or operative procedures (eg laparotomy, hysterectomy) or death After 60 minutes and at discharge
Secondary Outcome Mean blood loss within 60 minutes after enrollment. 60 minutes
Secondary Outcome Blood loss within 60 minutes after enrollment >500ml (lognormal distribution comparison) or operative procedures (eg laparotomy, hysterectomy) or death Continuous until discharge
Secondary Outcome Blood pressure, pulse and shock index 10 minutes after enrolment 10 minutes
Secondary Outcome Change in Haemoglobin levels pre- delivery to post delivery Pre-delivery and post intervention
Secondary Outcome Blood transfusion or death Continuous until discharge
Secondary Outcome ICU admission or death Continuous until discharge
Secondary Outcome Death Continuous until discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Frere Maternity Hospital Amalinda Drive East London 5201 South Africa
Cecilia Makiwane Hospital Billie Rd Mdantsane 5201 South Africa
Chris Hani Baragwanath Hospital Sowto highway Soweto 2000 South Africa
Department of Gynecology and Obstetrics. Clinical research center. Valle del Lili Foundation Cali Colombia
FUNDING SOURCES
Name of source Street address City Postal code Country
New Venture Fund 1201 Connecticut Ave, NW Suite 300 Washington DC 20036 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand York Rd, Parktown JHB 2000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Mandisa Singata Madliki Frere Hospital, Amalinda Drive East London 5201 South Africa
Dr Poovy Naidoo C H Baragwanath Hospital, Soweto Main Rd Soweto 2000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justus Hofmeyr justhof@gmail.com +27832809402 Frere Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director ECRU
Role Name Email Phone Street address
Public Enquiries Justus Hofmeyr justhof@gmail.com +27832809402 Frere Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director ECRU
Role Name Email Phone Street address
Scientific Enquiries Justus Hofmeyr justhof@gmail.com +27832809402 Frere Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director ECRU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes clincal data including baseline data and outcomes Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Controlled access as assessed by trial steering committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information