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NCT03870256·Not applicable·INTERVENTIONAL

Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

CarbetocinOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

135

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery

Full detailed description

Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.

Interventions

Treatment arms and agents.

DRUG

misoprostol

Patient receive 600mic gm sublingual misoprostol

DRUG

Carbetocin

Patient receive 100 mic gm carbetocin IV

DRUG

TA

The patient receives 1gm oral tranexamic acid

Timeline

From registration to results.

  1. First posted

    Mar 12, 2019

  2. Study start

    Apr 1, 2019

  3. Primary completion

    Aug 1, 2021

  4. Study completion

    Sep 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

the amount of blood loss by gm calculated by gravimetric methods

Secondary outcomes

number of patients loss more than 1000 ml blood

Time frame · 24 hours post delivery

calculate number of patients loss more than 1000 ml blood

need of uterotonics

Time frame · 24 hours post delivery

number of patients need of uterotonics

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: * were 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.

AswanUH

Aswān, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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.

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