Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery

NCT03710304 | Completed DMC

• 1 other identifier: aswu/173/7/18
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety. Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CD has not been investigated as much. The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Tranexamic acid(TA) is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analog; ε-aminocaproic acid. The aim of this study was to compare the effectiveness of combined buccal misoprostol and intravenous TA with intravenous oxytocin for the prevention of PPH in patients with risk factors during cesarean section.

Conditions

Cesarean Section Complications

Keywords

cesarean section; tranexamic acid; postpartum hemorrhage; buccal misoprostol

Outcome Measures

Primary Outcomes (1)

• number of participant required of additional pharmacological uterotonic.

  the number of participant need for extra uterotonic drug

  24 hours post operative

Secondary Outcomes (3)

• difference between preoperative and postoperative hemoglobin

  24 hours post operative

• intraoperative blood loss

  during the operation

• post operative blood loss

  24 hours post operative

Study Arms (2)

oxytocin

ACTIVE COMPARATOR

20 IU oxytocin ampoules in 500 mL of intravenous solution infusion over 15 min after delivery of the baby.plus 2tab placebo buccal(ranitidine) plus 110 ml saline iv

Drug: Oxytocin

Tranexamic acid plus misoprostol

ACTIVE COMPARATOR

400 μg misoprostol (2 tablets of 200 μg) or two placebo tablets were given buccally after spinal anesthesia and few minutes before skin incision; then 1 gm TA will be diluted in 100 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist before skin incision, plus 500 ml normal saline intravenous solution infusion over 15 min after delivery of the baby

Drug: Tranexamic acid plus misoprostol; Drug: misoprostol

Interventions

Oxytocin DRUG

20 IU oxytocin or placebo ampoules in 500 mL of intravenous solution infusion over 15 min after delivery of the baby.plus 2tab placebo buccal plus 110 ml saline by slow infusion

Also known as: Active Comparator

oxytocin

Tranexamic acid plus misoprostol DRUG

1 gm TA or separate placebo will be diluted in 100 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist before skin incision,

Also known as: Active Comparator

Tranexamic acid plus misoprostol

misoprostol DRUG

400 μg misoprostol (2 tablets of 200 μg) will be give buccally after spinal anesthesia and few minutes before skin incision;

Also known as: Active Comparator

Tranexamic acid plus misoprostol

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: patients scheduled for an elective cd with risk factors for atonic PPH during cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients scheduled for an elective cesarean section with risk factors for atonic PPH

You may not qualify if:

• Patients with a cardiac, hepatic, renal or thromboembolic disease
• patients had an allergy to tranexamic acid
• suspected coagulopathy
• history of coronary artery disease or hypertension
• patient refuses to participate

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Tranexamic Acid; Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; 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

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: participants will be randomized via a computer-generated random number sequence into one of two groups: one group received a pre-prepared sealed and opaque packet containing 400 μg of misoprostol (2 tablets of 200 μg), 2 ampoules of TA (1 gm for infusion) and separate placebo ampoule (distilled water). The other group received similar packets containing two placebo tablets, two placebo ampoules (distilled water) and separate 2 ampoules of oxytocin (syntocinon; 10 IU in each ampoule for infusion) for slow intravenous injection. The misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of oxytocin was also similar to placebo. Randomization was done by the resident doctors immediately before transfer to theater, whereas preparation of packets and confidential record maintenance was done by the labor room nursing staff. Study drug administration

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 18, 2018
• Study Start: November 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: June 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)