Placenta Previa Clinical Trial
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
Verified date | January 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 81 |
Est. completion date | January 5, 2023 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasralainy Cairo University | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The Use of additional ecbolics denoting uterine atony | The need for extra ecbolics will be recorded | Baseline | |
Secondary | The occurrence of excessive blood loss (> 1000 mL) within the first 24 hours postoperatively | Excessive blood loss will be recorded | First 24 hours postoperatively | |
Secondary | The need for blood transfusion | The need for blood transfusion will be recorded | During cesarean delivery and the first 24 hours postoperatively | |
Secondary | The occurrence of any maternal side effects in the studied groups | Maternal side effects will be recorded | First 6 hours postoperatively | |
Secondary | The occurrence of any neonatal outcome in the studied groups | Neonatal side effects will be recorded | The first 6 hours postoperatively |
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