Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

Aswan University Hospital

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: Carbetocin; Drug: oxytocin; Drug: oxytocin plus misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03870503

aswu/201/19

Details and patient eligibility

About

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

Full description

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.

Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Enrollment: 135 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation

Exclusion criteria

• gestational age<37 weeks,
• genital tract trauma,
• coagulation defect,
• women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
• known hypersensitivity to carbetocin or oxytocin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups

oxytocin

Active Comparator group

Description:

The patient will be received oxytocin 20 IU by intravenous infusion

Treatment:

Drug: oxytocin

oxytocin plus misoprostol

Active Comparator group

Description:

The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol

Treatment:

Drug: oxytocin plus misoprostol

Drug: oxytocin

Carbetocin

Active Comparator group

Description:

The patient will be received Carbetocin 100 mic gm IV

Treatment:

Drug: Carbetocin