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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a prospective double-blind randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This study will be a prospective double-blind randomized study

Study Groups

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oxytocin

The patient will be received oxytocin 20 IU by intravenous infusion

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

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 mc sublingual misoprostol

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

The patient will be received oxytocin 20 IU by intravenous infusion

oxytocin plus misoprostol

Intervention Type DRUG

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

Carbetocin

The patient will be received Carbetocin 100 mic gm IV

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

The patient received Carbetocin 100 mic gm

Interventions

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oxytocin

The patient will be received oxytocin 20 IU by intravenous infusion

Intervention Type DRUG

oxytocin plus misoprostol

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

Intervention Type DRUG

Carbetocin

The patient received Carbetocin 100 mic gm

Intervention Type DRUG

Other Intervention Names

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Active comparator Active Comparator Active Comparator

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No