CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Postpartum Hemorrhage

Treatments: Drug: Carbetocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03556852

38

Details and patient eligibility

About

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

Full description

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

Enrollment: 150 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

CARBETOCIN

Active Comparator group

Description:

received 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby.

Treatment:

Drug: Carbetocin

MISOPROSTOL

Active Comparator group

Description:

received 4 rectal misoprostol tablets (800 μg) after the delivery of the baby.

Treatment:

Drug: Misoprostol