DRUG
Carbetocin
1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby
Status
Completed
Phase
Phase 4
Enrollment
150
Locations
1
Results
Not posted
Publications
1
Study summary
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
Interventions
DRUG
1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby
DRUG
2 rectal misoprostol tablets (800 μg) after the delivery of the baby.
Timeline
First posted
Jun 14, 2018
Study start
Jul 2, 2018
Primary completion
May 24, 2019
Study completion
May 30, 2019
Results posted
Not reported
Registry updated
Oct 11, 2019
Outcomes
prevention of post partum hemorrhage after vaginal delivery
Time frame · 24 hours after delivery
Number of participants experienced postpartum hemorrhage
drugs side effects
Time frame · 24 hours after delivery
Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching
Eligibility
Inclusion Criteria: singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel \> 10 gm/dl • Noncomplicated pregnancy Exclusion Criteria: * Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Kasr Alainy medical school
Cairo, Egypt
Publications
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