Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorCairo University

About this trial

Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women booked for a primary elective cesarean section, not in active labor

Aged between 20-40 years.

BMI 18.5-29.9 kg/ m2 pre-pregnancy weight

Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days).

Disqualifiers

Placenta previa.

Maternal hypertension and Preeclampsia.

Diabetes mellitus.

Severe medical disorder (renal or hepatic).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic acid injection

    Drug

    In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.

  • Oxytocin

    Drug

    the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group 1: Tranexamic acid groupExperimental treatment 1 intervention
Group B: Group 2: oxytocin groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood loss

Estimation of Intraoperative and postoperative blood loss.

Time frame
24 hours

Secondary outcomes

1

Need of extra utero-tonic drugs

Need of extra utero-tonic drugs

Time frame
2 hours

Other outcomes

Sponsors and contacts

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