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Completed

NCT Number: NCT05340205

Blood Loss During Cesarean Delivery in Placenta Previa Patients

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kasralainy Cairo University

Giza, Egypt

About this study

Placenta previa is defined as complete or partial covering of the internal os of the cervix with the placenta, at more than 16 weeks of gestation. It affects 0.3% to 2% of pregnancies in the third trimester and has become more evident secondary to the increasing rates of cesarean delivery (CD).

Placenta previa is a major risk factor for postpartum hemorrhage (PPH) and can lead to maternal and neonatal morbidity and mortality. Uncontrolled PPH from placenta previa may necessitate blood transfusion, hysterectomy, admission to the intensive care unit, or even death.

The efficacy of routine administration of oxytocin, to reduce the frequency of PPH after vaginal and cesarean birth is well-established. The Royal College of Obstetricians and Gynecologists recommends a slow IV bolus dose of 5 IU of oxytocin after delivery of the neonate in CD to ensure adequate uterine contractility, reduce intraoperative blood loss and prevent PPH. Likewise, the American College of Obstetricians and Gynecologists recommends the practice to use oxytocin but infusion instead of a bolus dose. Regardless of the mode of administration, oxytocin use in the setting of CD may result in maternal adverse effects, such as hypotension and tachycardia.

Misoprostol, a prostaglandin E1 analogue with strong uterotonic properties binds to myometrial cells to cause strong myometrial contractions. Misoprostol has been suggested as an alternative to injectable uterotonic agents for preventing PPH following vaginal or CD. It can be used orally, sublingually, buccally, rectally or put intrauterine with similar efficacy as oxytocin in reducing blood loss, preventing and treating PPH. Because of its availability, low cost, thermal stability, and ease of administration, misoprostol is suitable for worldwide use even in low resource settings in developing countries.

Tranexamic Acid (TA) is an analogue of lysine that inhibits fibrinolysis by competitively binding to plasminogen. It prevents the lysis of formed clot by inhibiting activation of plasminogen and plasmin. It is ten times more potent than amino-caproic acid. Several studies had assessed the use of TA in both the prophylaxis against and the treatment of PPH with the conclusion that TA reduces the following; blood loss in women with PPH, the need for hysterectomy, the risk of severe anemia and the need for further blood transfusion; hence, this could contribute significantly to the goal of reducing maternal mortality

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Kapron

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).

.

Other names: Cytotec

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.

Other names: Syntocinon

Primary outcomes

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

    Time frame: less than 2 hours

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

Secondary outcomes

  1. The Use of additional ecbolics denoting uterine atony

    Time frame: Baseline

    The need for extra ecbolics will be recorded

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

    Time frame: First 24 hours postoperatively

    Excessive blood loss will be recorded

  3. The need for blood transfusion

    Time frame: During cesarean delivery and the first 24 hours postoperatively

    The need for blood transfusion will be recorded

  4. The occurrence of any maternal side effects in the studied groups

    Time frame: First 6 hours postoperatively

    Maternal side effects will be recorded

  5. The occurrence of any neonatal outcome in the studied groups

    Time frame: The first 6 hours postoperatively

    Neonatal side effects will be recorded

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Efficacy and Safety of Intrauterine Misoprostol Versus Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Delivery in Patients With Placenta Previa: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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