Blood Loss During Cesarean Delivery in Placenta Previa Patients

January 5, 2023 updated by: Noran Amin, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Kasralainy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tranexamic acid group
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
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
Active Comparator: Misoprostol group
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

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
Active Comparator: Oxytocin only (control) group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
less than 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Use of additional ecbolics denoting uterine atony
Time Frame: Baseline
The need for extra ecbolics will be recorded
Baseline
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
First 24 hours postoperatively
The need for blood transfusion
Time Frame: During cesarean delivery and the first 24 hours postoperatively
The need for blood transfusion will be recorded
During cesarean delivery and the first 24 hours postoperatively
The occurrence of any maternal side effects in the studied groups
Time Frame: First 6 hours postoperatively
Maternal side effects will be recorded
First 6 hours postoperatively
The occurrence of any neonatal outcome in the studied groups
Time Frame: The first 6 hours postoperatively
Neonatal side effects will be recorded
The first 6 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Tarek El Husseiny, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Placenta previa disorders

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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