Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida

NCT04635007 | Completed Phase 3

• 1 other identifier: AN2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the work is to compare the efficacy of preoperative IV tranexamic acid and rectal misoprostol in reducing blood loss in the elective cesarean section. Research question: In women undergoing elective cesarean section, is preoperative administration of IV tranexamic acid better than rectal misoprostol in reducing blood loss?

Conditions

Cesarean Section Complications; Blood Loss, Surgical; Misoprostol; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Estimation of Intraoperative and postoperative blood loss.

  6 hours

Secondary Outcomes (7)

• Maternal outcome

  6 hours

• Maternal outcome

  24 hours

• maternal outcome

  24 hours

• Maternal outcome

  24 hours

• Maternal outcome

  12 hours

Study Arms (2)

Group 1: Tranexamic acid group

EXPERIMENTAL

100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.

Drug: Tranexamic acid

Group 2: Misoprostol group

EXPERIMENTAL

100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).

Drug: Misoprostol 200mcg Tab

Interventions

Tranexamic acid DRUG

100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.

Also known as: Kapron

Group 1: Tranexamic acid group

Misoprostol 200mcg Tab DRUG

100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).

Also known as: Cytotic

Group 2: Misoprostol group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women booked for a primary elective cesarean section, not in active labor
• Aged between 18-40 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).
• Singleton pregnancies.
• Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes)
• Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age)
• Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these include fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008)

You may not qualify if:

• Placenta previa.
• Maternal hypertension and Preeclampsia.
• Diabetes mellitus.
• Severe medical disorder (renal or hepatic).
• Multiple Fibroid uterus.
• Multiple pregnancies.
• Polyhydramnios.
• Previous uterine surgery as myomectomy.
• Contraindication to spinal anesthesia.
• Blood coagulopathy and bleeding disorder.
• Marked maternal anemia (Preoperative hemoglobin \<9 gm/dl).
• Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol) or TXA

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Misoprostol

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mohammed A Taymour, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who will receive the actual drug and who will receive a placebo.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients will be divided into 2 groups Group no. (1) 100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally. Group no. (2) 100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

EG (1)