Blood Loss During Cesarean Delivery in Placenta Previa Patients

NCT05340205 | Completed Phase 4

• 1 other identifier: Placenta previa disorders
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety profile of intravenous tranexamic acid versus intrauterine misoprostol in reducing the blood loss during and after cesarean delivery in pregnant women diagnosed with placenta previa

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• To compare the estimated blood loss during cesarean delivery among the three groups

  The blood loss will be estimated in each of the three groups

  less than 2 hours

Secondary Outcomes (5)

• The Use of additional ecbolics denoting uterine atony

  Baseline

• The occurrence of excessive blood loss (> 1000 mL) within the first 24 hours postoperatively

  First 24 hours postoperatively

• The need for blood transfusion

  During cesarean delivery and the first 24 hours postoperatively

• The occurrence of any maternal side effects in the studied groups

  First 6 hours postoperatively

• The occurrence of any neonatal outcome in the studied groups

  The first 6 hours postoperatively

Study Arms (3)

Tranexamic acid group

ACTIVE COMPARATOR

Patients will receive 1 gm (10 ml) tranexamic acid diluted in 20 ml of Glucose 5% (administered as IV infusion over 5 minutes, at least 15 minutes prior to skin incision). Following the delivery of the baby, patients will additionally receive a slow IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h).

Drug: Tranexamic acid

Misoprostol group

ACTIVE COMPARATOR

Patients will receive 400 microgram misoprostol which will be inserted inside the uterus near the cornu after delivery of the placenta and swabbing the uterine cavity. Patients will additionally receive a slow IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h).

Drug: Misoprostol

Oxytocin only (control) group

ACTIVE COMPARATOR

Patients will receive only an IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby.

Drug: Oxytocin

Interventions

Tranexamic acid DRUG

Patients will receive 1 gm tranexamic acid diluted in 20 ml of Glucose 5% 15 minutes prior to skin incision and a slow IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following delivery of the baby.

Also known as: Kapron

Tranexamic acid group

Misoprostol DRUG

Patients will receive 400 microgram misoprostol which will be inserted inside the uterus near the cornu after delivery of the placenta and a slow IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h). .

Also known as: Cytotec

Misoprostol group

Oxytocin DRUG

Patients will receive an IV bolus of 5 IU oxytocin and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby.

Also known as: Syntocinon

Oxytocin only (control) group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Parity: primigravida or multigravida.
• Gestational age: ≥ 36 weeks (confirmed by the first day of the last menstrual period or first trimester ultrasound scan).
• Candidate for termination of pregnancy by cesarean delivery.
• Singleton living healthy normally growing fetus.
• Cesarean delivery under spinal anesthesia.
• Pregnancies complicated with placenta previa diagnosed preoperatively by ultrasonography (placenta previa was defined as placenta partially or totally covers the cervix)

You may not qualify if:

• Patients diagnosed with morbidly adherent placenta.
• Placenta previa cases requiring cesarean hysterectomy in the primary surgery.
• Patients with preoperative anemia (Hemoglobin \<9 gm/dl).
• History of thromboembolic event.
• Known allergy to tranexamic acid or prostaglandins.
• Bronchial asthma or other contraindications of misoprostol.
• Patients with other risk factors of postpartum hemorrhage (e.g., polyhydramnios, fetal macrosomia, uterine fibroid).
• Patients known to have bleeding tendency (e.g., those receiving anticoagulation, patients with thrombocytopenia, factor VIII or IX deficiency or Von Willebrand's disease).
• More than 2 previous cesarean deliveries procedures.
• Prolonged procedure (more than 2 hours from skin incision to skin closure).
• Concomitant maternal medical disorders (either chronic or pregnancy induced)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralainy Cairo University

Giza, Egypt

Location

Related Publications (7)

• Bhattacharya S, Ghosh S, Ray D, Mallik S, Laha A. Oxytocin administration during cesarean delivery: Randomized controlled trial to compare intravenous bolus with intravenous infusion regimen. J Anaesthesiol Clin Pharmacol. 2013 Jan;29(1):32-5. doi: 10.4103/0970-9185.105790.

  PMID: 23493050 BACKGROUND

• Martinelli KG, Garcia EM, Santos Neto ETD, Gama SGND. Advanced maternal age and its association with placenta praevia and placental abruption: a meta-analysis. Cad Saude Publica. 2018 Feb 19;34(2):e00206116. doi: 10.1590/0102-311X00206116.

  PMID: 29489954 BACKGROUND

• Prata N, Weidert K. Efficacy of misoprostol for the treatment of postpartum hemorrhage: current knowledge and implications for health care planning. Int J Womens Health. 2016 Jul 29;8:341-9. doi: 10.2147/IJWH.S89315. eCollection 2016.

  PMID: 27536161 BACKGROUND

• Pabinger I, Fries D, Schochl H, Streif W, Toller W. Tranexamic acid for treatment and prophylaxis of bleeding and hyperfibrinolysis. Wien Klin Wochenschr. 2017 May;129(9-10):303-316. doi: 10.1007/s00508-017-1194-y. Epub 2017 Apr 21.

  PMID: 28432428 BACKGROUND

• Sood AK, Singh S. Sublingual misoprostol to reduce blood loss at cesarean delivery. J Obstet Gynaecol India. 2012 Apr;62(2):162-7. doi: 10.1007/s13224-012-0168-2. Epub 2012 Jun 1.

  PMID: 23543254 BACKGROUND

• Vogel JP, West HM, Dowswell T. Titrated oral misoprostol for augmenting labour to improve maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Sep 23;2013(9):CD010648. doi: 10.1002/14651858.CD010648.pub2.

  PMID: 24058051 BACKGROUND

• Della Corte L, Saccone G, Locci M, Carbone L, Raffone A, Giampaolino P, Ciardulli A, Berghella V, Zullo F. Tranexamic acid for treatment of primary postpartum hemorrhage after vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(5):869-874. doi: 10.1080/14767058.2018.1500544. Epub 2018 Sep 10.

  PMID: 30122082 BACKGROUND

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic Acid; Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

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

Study Officials

• Tarek El Husseiny, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: May 4, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 5, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

EG (1)