Blood Loss During Cesarean Delivery in Placenta Previa Patients

Phase 4

Completed

• Conditions: Placenta Previa
• Interventions: Drug: Tranexamic acid; Drug: Oxytocin; Drug: Misoprostol

• Registration Number: NCT05340205
• Lead Sponsor: Cairo University

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-22
• Study Start: 2022-05-04
• Primary Completion: 2022-12-15
• Status Verified: 2023-01
• Study Completion: 2023-01-05
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid group	Tranexamic acid	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).
Oxytocin only (control) group	Oxytocin	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.
Misoprostol group	Misoprostol	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).

Primary Outcome Measures

Name	Time	Method
To compare the estimated blood loss during cesarean delivery among the three groups	less than 2 hours	The blood loss will be estimated in each of the three groups

Secondary Outcome Measures

Name	Time	Method
The Use of additional ecbolics denoting uterine atony	Baseline	The need for extra ecbolics will be recorded
The occurrence of excessive blood loss (> 1000 mL) within the first 24 hours postoperatively	First 24 hours postoperatively	Excessive blood loss will be recorded
The need for blood transfusion	During cesarean delivery and the first 24 hours postoperatively	The need for blood transfusion will be recorded
The occurrence of any maternal side effects in the studied groups	First 6 hours postoperatively	Maternal side effects will be recorded
The occurrence of any neonatal outcome in the studied groups	The first 6 hours postoperatively	Neonatal side effects will be recorded

Trial Locations

Locations (1)

Kasralainy Cairo University; 🇪🇬 Giza, Egypt