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.: PACTR201809584199573 Date of Approval: 11/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of uterine suction tamponade on blood loss during caesarean section
Official scientific title The effect of uterine suction tamponade on blood loss during caesarean section
Brief summary describing the background and objectives of the trial Background Haemorrhage after caesarean section (CS) has been identified as an increasing cause of maternal mortality in South Africa, with calls from the Committee on Confidential Enquiries into Maternal Deaths to seek ways to reduce blood loss at CS . Uterine suction tamponade (UST) is an intuitively attractive procedure because it is aligned with the physiological mechanism of postpartum haemostasis (uterine contraction). Negative pressure is applied via a catheter in the uterine cavity. Observational studies of UST used prophylactically or therapeutically at CS have reported positive results. One of the limiting factors in prevention of haemorrhage at CS is the need to restrict oxytocin dosage due to the hypotensive effect of oxytocin. UST represents a simple, immediate local method of reducing blood loss without systemic effects. If confirmed to be effective, use of UST at CS could reduce the risks of CS and need for postoperative blood product transfusion. Objective To compare the effect on blood loss at CS of UST versus control (delayed UST).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UVT at CS
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 17/09/2018
Actual trial start date 15/10/2018
Anticipated date of last follow up 14/12/2018
Actual Last follow-up date 23/11/2018
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Completed
Publication URL https://www.ncbi.nlm.nih.gov/pubmed/31206652
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Uterine vacuum tamponade Single application From closure of uterine incision until 5 minutes after skin closure Before or after removal of the placenta and checking that the uterus is empty, the catheter will be passed from above through the cervix and vagina to be retrieved from under the drapes by the floor nurse, and attached to the UVT suction bottle.The suction tubing from the suction machine will be routed via a concealed vent with a 3-way tap with 3 settings: ‘closed’ ‘A’ and ‘B’. Settings ‘A’ and ‘B’ will be open and closed settings. In the open setting (A or B), the vacuum source will be inactivated by the vent. The floor nurse will set the vent to a closed position (‘A’ or ‘B’) according to a random allocation sequence in a set of sealed envelopes. The suction catheter will be placed in the upper uterine segment. As soon as the uterine incision is closed, the time will be noted and suction machine switched on. The CS will be completed routinely. After skin closure, the floor nurse will switch the concealed vent to the ‘closed’ position. After 5 minutes, the catheter will be removed and any remaining blood or clots massaged from the uterus and vagina into another receiver. 23
Control Group Delayed UVT Single application From Skin closure for 5 minutes Before or after removal of the placenta and checking that the uterus is empty, the catheter will be passed from above through the cervix and vagina to be retrieved from under the drapes by the floor nurse, and attached to the UVT suction bottle.The suction tubing from the suction machine will be routed via a concealed vent with a 3-way tap with 3 settings: ‘closed’ ‘A’ and ‘B’. Settings ‘A’ and ‘B’ will be open and closed settings. In the open setting (A or B), the vacuum source will be inactivated by the vent. The floor nurse will set the vent to the open position (‘A’ or ‘B’) according to a random allocation sequence in a set of sealed envelopes. The suction catheter will be placed in the upper uterine segment. As soon as the uterine incision is closed, the time will be noted and suction machine switched on. The CS will be completed routinely. After skin closure, the floor nurse will switch the concealed vent to the ‘closed’ position so that suction will be applied to the delayed UST group. After 5 minutes, the catheter will be removed and any remaining blood or clots massaged from the uterus and vagina into another receiver. 23 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Low-risk pregnant women Age 18 years or more Undergoing elective CS, or CS in early labour when sufficiently comfortable to complete consent procedures without distress. Sign informed consent Any complications which would contra-indicate the use of UVT Adult: 19 Year-44 Year 18 Year(s) 55 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 31/07/2018 Human Research Ethics Committee University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
York Roade, Parktown Johannesburg 2193 South Africa
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 10/09/2018 Human Research Ethics Committee University of the Witwatersranc
Ethics Committee Address
Street address City Postal code Country
York Road, Parktown Johannesburg 2139 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measured uterine blood loss during CS and until 5 min after completion From closure of uterine incision until 5 minutes after closure of skin incision
Secondary Outcome Duration of operation From skin incision until skin closure
Secondary Outcome Blood transfusion From randomization until discharge from hospital
Secondary Outcome Postoperative haemoglobin minus pre-operative haemoglobin Last preoperative haemoglobin measurement until first postoperative haemoglobin measurement
Secondary Outcome Highest postoperative temperature From skin closure until discharge from hospital
Secondary Outcome Wound infection From skin closure until discharge from hospital
Secondary Outcome Endometritis From skin closure until discharge from hospital
Secondary Outcome Postnatal complications From skin closure until discharge from hospital
Secondary Outcome Time from surgery to discharge (days) From skin closure until discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Frere Maternity Hospital Amalinda Drive East London 5201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Meiring Naude Rd Pretoria 0184 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand York Rd, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Mandisa SingataMadliki Amailinda Drive East London 5201 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Justus Hofmeyr justhof@gmail.com 0437091111 Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director Effective Care Research Unit
Role Name Email Phone Street address
Public Enquiries Mandisa SingataMadliki mandisa.singata@gmail.com 0437091111 Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Deputy Director Effective Care Research Unit
Role Name Email Phone Street address
Scientific Enquiries George Justus Hofmeyr justhof@gmail.com 0437091111 Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director Effective Care Research Unit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Ananymised dataset of trial baseline data and outcomes Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After primary publication Protocol approved by ethics 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