Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

Aswan University Hospital

Status: Completed

Conditions: Post Partum Hemorrhage

Treatments: Drug: TA; Drug: misoprostol; Drug: Carbetocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03870256

aswu/200/19

Details and patient eligibility

About

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 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.

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

135 participants in 2 patient groups

TA plus misoprostol

Active Comparator group

Description:

Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm

Treatment:

Drug: misoprostol

Drug: TA

Carbetocin

Active Comparator group

Description:

Patient receives 100 mic gm carbetocin IV

Treatment:

Drug: Carbetocin