Anemia Clinical Trial
Official title:
Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail
The objective of this study is to assess the effect of TA treatment on decline in Hb levels following vaginal delivery with an episiotomy, compared to a control group not receiving TA.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | July 10, 2024 |
Est. primary completion date | August 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. women aged 18-45 2. 37-42 weeks gestation 3. Singleton pregnancy 4. Cephalic presentation Exclusion Criteria: 1. Any contra-indication for vaginal birth 2. PPH risk factors 1. Dysfunctional labor 2. Over distended uterus (macrosomia ,Polyhydramnios,multiple gestation) 3. Grand multiparity 4. Chorioamnionitis 5. Precipitous labor 6. Operative delivery 7. Prolonged second stage 3. Previous pph 4. Preeclampsia 5. Placental abruption 6. Previous cesarean delivery 7. Thrombophilia or coagulopathy 8. Allergy to TA |
Country | Name | City | State |
---|---|---|---|
Israel | Assuta ashdod | Ashdod | Shfela |
Lead Sponsor | Collaborator |
---|---|
Assuta Ashdod Hospital |
Israel,
Carbillon L, Uzan M, Uzan S. Pregnancy, vascular tone, and maternal hemodynamics: a crucial adaptation. Obstet Gynecol Surv. 2000 Sep;55(9):574-81. doi: 10.1097/00006254-200009000-00023. — View Citation
Kramer MS, Berg C, Abenhaim H, Dahhou M, Rouleau J, Mehrabadi A, Joseph KS. Incidence, risk factors, and temporal trends in severe postpartum hemorrhage. Am J Obstet Gynecol. 2013 Nov;209(5):449.e1-7. doi: 10.1016/j.ajog.2013.07.007. Epub 2013 Jul 16. — View Citation
Rossen J, Okland I, Nilsen OB, Eggebo TM. Is there an increase of postpartum hemorrhage, and is severe hemorrhage associated with more frequent use of obstetric interventions? Acta Obstet Gynecol Scand. 2010 Oct;89(10):1248-55. doi: 10.3109/00016349.2010.514324. — View Citation
Sosa CG, Althabe F, Belizan JM, Buekens P. Risk factors for postpartum hemorrhage in vaginal deliveries in a Latin-American population. Obstet Gynecol. 2009 Jun;113(6):1313-1319. doi: 10.1097/AOG.0b013e3181a66b05. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta Hb levels | Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth) | 24 hours from delivery | |
Secondary | PPH rate | early post partum hemorrhage | 24 hours from delivery | |
Secondary | Uterotonics use | Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no | 24 hours from delivery | |
Secondary | Blood transfusion | Use of Blood packed cells during hospitalization, dichotomies scale - yes or no | 72 hours from delivery | |
Secondary | hospital admission | Number of hospital admission days | 120 hours from delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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