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Blood Loss During Cesarean Delivery in Placenta Previa Patients

Primary Purpose

Placenta Previa

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid
Misoprostol
Oxytocin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Kasralainy Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tranexamic acid group

Misoprostol group

Oxytocin only (control) group

Arm Description

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).

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2022
Last Updated
January 5, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05340205
Brief Title
Blood Loss During Cesarean Delivery in Placenta Previa Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Misoprostol group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Oxytocin only (control) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Kapron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Description
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). .
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare the estimated blood loss during cesarean delivery among the three groups
Description
The blood loss will be estimated in each of the three groups
Time Frame
less than 2 hours
Secondary Outcome Measure Information:
Title
The Use of additional ecbolics denoting uterine atony
Description
The need for extra ecbolics will be recorded
Time Frame
Baseline
Title
The occurrence of excessive blood loss (> 1000 mL) within the first 24 hours postoperatively
Description
Excessive blood loss will be recorded
Time Frame
First 24 hours postoperatively
Title
The need for blood transfusion
Description
The need for blood transfusion will be recorded
Time Frame
During cesarean delivery and the first 24 hours postoperatively
Title
The occurrence of any maternal side effects in the studied groups
Description
Maternal side effects will be recorded
Time Frame
First 6 hours postoperatively
Title
The occurrence of any neonatal outcome in the studied groups
Description
Neonatal side effects will be recorded
Time Frame
The first 6 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek El Husseiny, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Kasralainy Cairo University
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
23493050
Citation
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.
Results Reference
background
PubMed Identifier
29489954
Citation
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.
Results Reference
background
PubMed Identifier
27536161
Citation
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.
Results Reference
background
PubMed Identifier
28432428
Citation
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.
Results Reference
background
PubMed Identifier
23543254
Citation
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.
Results Reference
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PubMed Identifier
24058051
Citation
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.
Results Reference
background
PubMed Identifier
30122082
Citation
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.
Results Reference
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Blood Loss During Cesarean Delivery in Placenta Previa Patients

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