Postpartum Haemorrhage Clinical Trial
Official title:
Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Verified date | March 2020 |
Source | Benha University |
Contact | khalid ibrahim, MD |
dr.khalidkhader77[@]yahoo.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
the investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of additional uterotonics and need for blood transfusion.
Status | Recruiting |
Enrollment | 520 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 49 Years |
Eligibility |
Inclusion Criteria: 1. Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester 2. Women at high risk for primary atonic postpartum hemorrhage - Over distended uterus - Large fetus - Multiple fetuses - Hydramnios - Distension with clots accidental hemorrhage - Exhausted myometrium - Prolonged labor - Oxytocin or prostaglandin stimulation - Chorioamnionitis - Previous uterine atony - Placenta previa - Marked anemia Exclusion Criteria: 1. Cervical tear 2. extensive birth canal tear 3. Postpartum hemorrhage 4. Retained placenta 5. Coagulopathy 6. Chronic medical illness hepatic renal 7. Pregnancy induced hypertension PIH 8. Refusal to participate in the study |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha univesity hospital and afhsa | Banha | El Qualyobia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood loss 500 ml or more after enrolment | estimating blood loss from vagina | 60 minutes after enrolment | |
Secondary | Blood loss 1000 ml or more after enrolment | estimating blood loss by collecting it | (up to 30 and 60 minutes) after enrolment | |
Secondary | Use of additional uterotonics or other procedures | giving drugs IV | 60 minutes | |
Secondary | Blood transfusion | giving how many units of PRBCS | 60 minutes |
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