Current partner codePEPTIDESDE
NCT03870503·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

135

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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 detailed 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.

Interventions

Treatment arms and agents.

DRUG

oxytocin

The patient will be received oxytocin 20 IU by intravenous infusion

DRUG

oxytocin plus misoprostol

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

DRUG

Carbetocin

The patient received Carbetocin 100 mic gm

Timeline

From registration to results.

  1. First posted

    Mar 12, 2019

  2. Study start

    Apr 1, 2019

  3. Primary completion

    Jun 30, 2021

  4. Study completion

    Aug 1, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Sep 29, 2021

Outcomes

What the study measures.

Primary outcomes

The amount of blood loss

Time frame · 6 hours post delivery

calculation of the amount of blood loss by weighing the swabs and using pictorial charts

Secondary outcomes

The number of patients develop blood loss more than 1000 ml

Time frame · 24 hours post delivery

Calculation of the number of patients develop blood loss more than 1000 ml

The number of patient need blood transfusion

Time frame · 24 hours post delivery

Calculation of number of patient need blood transfusion

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Aswan University Hospital

Aswān, Egypt

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.