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Trial registered on ANZCTR


Registration number
ACTRN12613000348752
Ethics application status
Approved
Date submitted
26/03/2013
Date registered
2/04/2013
Date last updated
2/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The prophylactic use of a Bakri balloon for women undergoing caesarean section for placenta praevia – a randomised controlled trial
Scientific title
Amongst women undergoing caesarean section for placenta praevia does prophylacitc use of a Bakri intrauterine balloon immediately following delivery of placenta compared with usual measures reduce blood loss and/or the need for additional surgical/pharmacological measures to reduce blood loss
Secondary ID [1] 282185 0
Nil known
Universal Trial Number (UTN)
U1111-1141-0806
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy
288698 0
placenta praevia 288729 0
Condition category
Condition code
Reproductive Health and Childbirth 289047 289047 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 289084 289084 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For women randomised to the Bakri arm, the Bakri device package is opened following delivery of placenta and the stopcock removed from the inflation port at the end of the device. The balloon should be placed (un-inflated) in the uterine cavity. Using a long Harrison forcep the inflation port end of the balloon device should be fed through the cervix from above and retrieved by an assistant (non-sterile) vaginally. The stopcock is then to be re-attached to the inflation port by the assistant. Meanwhile the first layer of closure of the uterine incision should be undertaken. Following this, 100ml of sterile water should be inflated into the Bakri balloon. The second layer uterine closure should now be performed taking care not to damage the underlying semi-inflated balloon device. After 2 layer uterine closure, the balloon device should be further inflated (up to a maximum total instilled volume of no more than 500ml) until the uterus is ‘firm’. In the event that the clinician is concerned regarding bleeding, any and all alternative surgical and/or pharmacological measures of achieving haemostasis can now be employed. This may include (but is not limited to) increased rate/duration/concentration of Syntocinon infusion, Misoprostol, Ergometrine, B-lynch or other compression suture, Ergometrine, PGF2-alpha, ligation of uterine/ovarian/internal iliac arteries, hysterectomy. At conclusion of the caesarean section, the surgeon should perform a vaginal examination to confirm that the balloon is in the uterine cavity. A Betadine soaked 1-inch vaginal pack should be introduced to reduce the risk of the balloon being expelled into the vagina. The urethral Foley catheter is to remain in situ until Bakri removed and subsequent vaginal loss assessed. The balloon device is to remain in-situ for no less than 17 hours and no more than 23 hours. The Bakri balloon should be deflated fully, but remain in-situ (deflated) for a further 1 hour to observe for ongoing blood loss in the Bakri collection bag. After 1 hour, the vaginal pack should be removed and the deflated Bakri balloon removed. Subsequent vaginal loss should be recorded up to 36 hours post-birth.

Intervention code [1] 286792 0
Treatment: Surgery
Comparator / control treatment
Women randomised to the control arm are to undergo a similar 2 layer uterine closure. The clinician is free to employ any and all alternative surgical and/or pharmacological measures of achieving haemostasis. This may include (but is not limited to) increased rate/duration/concentration of Syntocinon infusion, Misoprostol, Ergometrine, B-lynch or other compression suture, Ergometrine, PGF2 alpha, ligation of uterine/ovarian/internal iliac arteries, hysterectomy. Note: this includes the option of a Bakri balloon.
Control group
Active

Outcomes
Primary outcome [1] 289158 0
Clinician’s decision to undertake further intervention to control bleeding (eg increased rate/duration/concentration of Syntocinon infusion, Misoprostol, Ergometrine, B-lynch or other compression suture, Ergometrine, PGF2 alpha, ligation of uterine/ovarian/internal iliac arteries, hysterectomy). The use of any additional measures will be determined following a review of the intraoperative documentation by the research midwife and this information will be recorded on a dedicated data collection form.
Timepoint [1] 289158 0
Within the first 24 hours after birth.
Primary outcome [2] 289159 0
Change in haemoglobin, This will be assessed by the research midwife by reviewing the routine pre-operative and post-operative full blood examination results. The information will be recorded on a dedication data collection form
Timepoint [2] 289159 0
The haemoglobin measured as part of routine pre-operative bloods (performed between 1hour and 72 hours pre-op) will be compared with post-operative haemoglobin (performed between 14h and 24 hours post-op)
Secondary outcome [1] 301945 0
Number of units of red blood cells transfused, will be assessed following review of the medical record
Timepoint [1] 301945 0
Measured at any time from delivery of baby until 36 hours postbirth
Secondary outcome [2] 302007 0
Combined intraoperative and postoperative blood loss.

Intraoperative blood loss is to be determined by consensus of the surgeon, anaesthetist and theatre nursing staff.

Post–operative blood loss includes blood loss from the time of leaving the operating suite until 36 hours after birth of the baby. This will be determined by the research midwife using some/all of the following pieces of information
i) measured loss in Bakri bag
ii) measured loss in intra-abdominal drains
iii) estimated millilitre loss as documented by treating practitioners in the medical record and/or observation sheets
iv) pad loss where scant loss = 10mls, light loss = 15mls, moderate loss= 30mls, heavy loss =60mls, soaked or clots = 100mls
v) ‘bluey’ loss where scant loss = 20mls, light loss = 50mls, moderate loss= 150mls, heavy loss =250mls, soaked or clots = 400mls
vi) vaginal pack loss where scant = 20mls, moderate = 100mls, soaked =300mls
Timepoint [2] 302007 0
Blood loss includes blood loss from the time of leaving the operating suite until 36 hours after birth of the baby.
Secondary outcome [3] 302008 0
Endometritis.

The diagnosis of endometritis will be determined as an inpatient
1) if antibiotics are administered beyond 24 hours post-birth and the treating clinician documents “endometritis” in the case notes OR
2) if antibiotics are administered beyond 24 hours post-birth in the absence of presumed urinary tract infection, breast infection, chest infection or wound infection

The diagnosis of endometritis will be determined as an outpatient (by phone call to woman at 4 weeks post-birth)
1) if antibiotics were administered after discharge from hospital because of heavy bleeding and/or discharge and/or lower abdominal pain OR
2) if antibiotics were administered after discharge from hospital for a reason other than presumed urinary tract infection, breast infection, chest infection or wound infection
Timepoint [3] 302008 0
Anytime during the first 4 weeks post-partum

Eligibility
Key inclusion criteria
All women with live singleton pregnancies =24+0 weeks undergoing caesarean section in the setting of a known placenta praevia (leading edge of placenta <20mm from the cervical os) will be suitable for inclusion in this study
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple pregnancy
Intrauterine Fetal Death
Suspected placenta accreta
Congenital abnormalities of the uterine cavity
Submucosal uterine fibroids >5cm
Women who give birth vaginally
Women aged <18 years
Inability to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified by the research midwife via antenatal clinic records after their repeat scan at 32 weeks confirms a persistent placenta praevia (where the leading edge of the placenta is <20mm from the cervical os). The Obstetrician will discuss the trial with the woman and if she meets inclusion criteria, the research midwife will provide her with written information about the trial. Women will be given the opportunity to discuss the details of the study with the research midwife by telephone in 5-7 days time. If the woman expresses a desire to be involved she will be invited to sign a consent form to participate in the trial when she attends her next planned antenatal appointment. The research midwife will obtain consent and arrange randomisation and a staff information sheet will be filed in the medical record. The research midwife will keep a log of all potentially eligible participants and the reasons for participation or not as per CONSORT guidelines. Sealed opaque envelopes will be prepared by MMRC and stored by the research midwife securely in the Antenatal Clinic. The envelope will be opened by the research midwife in the antenatal clinic after obtaining written consent
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be according to computer-generated random allocation list into 2 study arms. Given the nature of the proposed intervention (presence or absence of an intrauterine Balloon device) it is not possible to blind either clinicians or the patient as to their allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A sample size of 100 would detect
a) a difference in preoperative to postoperative haemoglobin of 1g (12-10 vs 12-9g/dL)
b) a difference in the proportion of cases requiring further haemostatic intervention (25% vs 5%)
with a power of 80% and a type 1 error of 0.05

These assumptions are based on Frederiken’s series of 514 caesarean sections performed for placenta praevia and their mean pre-operative to post-operative haemoglobin change. Secondly, considering that the incidence of blood transfusion for women undergoing caesarean section for placenta praevia is increased some 10-fold, it is assumed the rate of haemostatic intervention also increases proportionately. Finally, presuming there are approximately 100 potentially eligible women each year, and that 2/3 of these women will consent to take part, it will take approximately 18 months to achieve a sample size of 100 women.

The initial analysis will assess the adequacy of randomisation procedure in ensuring comparability of the study groups. In this analysis demographic and other baseline characteristics will be compared. Primary and secondary outcomes will be assessed comparing the study groups. The Chi squared test will be used for categorical outcomes and student’s t-test for data measured on a continuous scale. If imbalance is identified in important baseline characteristics or demographics, a second analysis will be undertaken controlling for these factors using multivariate analysis. The level of significance for the primary outcome measures is set at 0.05 and Bonferroni adjustment for multiple comparisons will be undertaken for secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 796 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 6616 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 286952 0
Commercial sector/Industry
Name [1] 286952 0
Cook Medical
Address [1] 286952 0
1025 Acuff Road, P.O. Box 4195
Bloomington, IN 47402-4195 USA

Country [1] 286952 0
United States of America
Primary sponsor type
Individual
Name
Michael Beckmann
Address
Mater Health Services
Raymond Tce
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 285738 0
University
Name [1] 285738 0
Mater Medical Research Institute
Address [1] 285738 0
Raymond Terrace
South Brisbane, QLD 4101
Country [1] 285738 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289005 0
Mater Health Services HREC
Ethics committee address [1] 289005 0
Raymond Tce
South Brisbane, QLD 4101
Ethics committee country [1] 289005 0
Australia
Date submitted for ethics approval [1] 289005 0
01/08/2009
Approval date [1] 289005 0
01/09/2009
Ethics approval number [1] 289005 0
1316M

Summary
Brief summary
Placenta praevia remains a significant cause of peri-partum morbidity. It is associated with an increased risk of postpartum haemorrhage and subsequent surgical procedures to control bleeding including caesarean hysterectomy. The use of the Bakri balloon prophylactically at the time of caesarean section may provide a significant benefit in reducing blood loss and avoiding the need for other more extensive surgical procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38754 0
Dr Michael Beckmann
Address 38754 0
Ground Floor Aubigny Place
Raymond Tce
South Brisbane, QLD 4101
Country 38754 0
Australia
Phone 38754 0
+61 7 3163 1594
Fax 38754 0
+61 7 3163 1949
Email 38754 0
michael.beckmann@mater.org.au
Contact person for public queries
Name 38755 0
Dr Michael Beckmann
Address 38755 0
Ground Floor Aubigny Place
Raymond Tce
South Brisbane, QLD 4101
Country 38755 0
Australia
Phone 38755 0
+61 7 3163 1594
Fax 38755 0
+61 7 3163 1949
Email 38755 0
michael.beckmann@mater.org.au
Contact person for scientific queries
Name 38756 0
Dr Michael Beckmann
Address 38756 0
Ground Floor Aubigny Place
Raymond Tce
South Brisbane, QLD 4101
Country 38756 0
Australia
Phone 38756 0
+61 7 3163 1594
Fax 38756 0
+61 7 3163 1949
Email 38756 0
michael.beckmann@mater.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary