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

Postpartum Hemorrhage Clinical Trial

Official title:

Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870503
• Other study ID #: aswu/201/19
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• oxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
• oxytocin plus misoprostol
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
• Carbetocin
The patient received Carbetocin 100 mic gm

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of blood loss	calculation of the amount of blood loss by weighing the swabs and using pictorial charts	6 hours post delivery
Secondary	The number of patients develop blood loss more than 1000 ml	Calculation of the number of patients develop blood loss more than 1000 ml	24 hours post delivery
Secondary	The number of patient need blood transfusion	Calculation of number of patient need blood transfusion	24 hours post delivery