Home » Trials » SLCTR/2011/010
Anticipatory management vs standard management of postpartum haemorrhage
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SLCTR Registration Number
SLCTR/2011/010
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Anticipatory management vs standard management of postpartum haemorrhage
Public Title of Trial
Anticipatory management vs standard management of postpartum haemorrhage
Disease or Health Condition(s) Studied
Postpartum haemorrhage (PPH)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-10-136 (Ethics Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is anticipatory management better for postpartum haemorrhage than standard mangement?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Intervention group will receive anticipatory management protocol while the control group will receive standard management protocol. Standard management. If visually assessed blood loss is ? 500ml or if cardiovascular instability initiate PPH management. Anticipatory Management. If there is continuous fresh bleeding after delivery of the placenta not responding to uterine massage, initiate PPH management
Inclusion criteria
Giving birth after 36 Weeks of amenorrhea •Post-partum haemorrhage due to uterine atony (recognized by continuing bleeding not responding to uterine massage and excluding other causes after examination)
Exclusion criteria
•Anomalies of hemostasis before labour •Anticoagulant treatment •Patients with death in utero fetuses •Diagnosed patients with placenta accreta or percreta
Primary outcome(s)
|
1.
Need for use of balloon tamponade to control PPH |
[ Until 24hours postpartum ] |
Secondary outcome(s)
|
1.
• Percentage of women who did not develop PPH in the standard treatment arm • Need for additional intervention after initial PPH treatment • Use of additional doses of oxytocin/ ergometrine • Surgical interventions • Compressive sutures • Systematic pelvic devascularization (Uterine, Internal iliac artery ligation) • Hysterectomy • Change in hemoglobin from pre-delivery to postpartum • Receipt of blood transfusion Need for massive blood transfusion (>5 units of blood) • Maternal death |
[ Until study subject is discharged from hospital ] |
Target number/sample size
126 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2011-07-31
Anticipated end date
2013-07-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2011-05-19
Approval number
EC-10-136
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Hemantha Senanayake
Department of Obstetrics & Gynaecology, University of Colombo
0112556340
0714762176
senanayakeh@gmail.com
Contact Person for Public Queries
Prof. Hemantha Senanayake
Department of Obstetrics & Gynaecology, University of Colombo
0112556340
0714762176
senanayakeh@gmail.com
Primary study sponsor/organization
Faculty of Medicine, Colombo
25, Kynsey Road, Colombo 08
2695300
gynobscmb@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
