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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2011/010 |
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Date of registration:
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25/07/2011 |
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Primary sponsor: |
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Public title:
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Anticipatory management vs standard management of postpartum haemorrhage
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Scientific title:
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Anticipatory management vs standard management of postpartum haemorrhage |
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Date of first enrolment:
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31/7/2011 |
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Target sample size:
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126 in each arm |
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Recruitment status: |
Pending |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={B609ECE3-CC78-429B-A2BC-9B803AF4A88D} |
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Study type:
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Interventional |
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Study design:
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“Randomised controlled trial. All antenatal mothers who are attending routine clinics at 36 or more weeks of POG will be recruited after informed consent. Consenting mothers with continuous fresh bleeding following vaginal delivery will be randomized”
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Prof. Hemantha Senanayake
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Address:
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Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo
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Telephone:
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0714762176 |
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Email:
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senanayakeh@gmail.com |
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Affiliation:
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Name:
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Prof. Hemantha Senanayake
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Address:
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Department of Obstetrics and Gynaecology, University of Colombo
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Telephone:
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0714762176 |
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Email:
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senanayakeh@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Postpartum haemorrhage (PPH)
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Intervention(s)
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Intervention group will receive anticipatory management protocol while the control group will receive standard management protocol.
Standard management.
If visually assessed blood loss is and#8805; 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
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Primary Outcome(s)
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Need for use of balloon tamponade to control PPH
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Secondary Outcome(s)
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• 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
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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None
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