Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail
Primary Purpose
Episiotomy Wound, Anemia, Early Postpartum Hemorrhage
Status
Recruiting
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Episiotomy Wound
Eligibility Criteria
Inclusion Criteria:
- women aged 18-45
- 37-42 weeks gestation
- Singleton pregnancy
- Cephalic presentation
Exclusion Criteria:
- Any contra-indication for vaginal birth
PPH risk factors
- Dysfunctional labor
- Over distended uterus (macrosomia ,Polyhydramnios,multiple gestation)
- Grand multiparity
- Chorioamnionitis
- Precipitous labor
- Operative delivery
- Prolonged second stage
- Previous pph
- Preeclampsia
- Placental abruption
- Previous cesarean delivery
- Thrombophilia or coagulopathy
- Allergy to TA
Sites / Locations
- Assuta ashdodRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hexakakapron group
control group
Arm Description
women with an episiotomy after vaginal delivery
women with an episiotomy after vaginal delivery
Outcomes
Primary Outcome Measures
Delta Hb levels
Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth)
Secondary Outcome Measures
PPH rate
early post partum hemorrhage
Uterotonics use
Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no
Blood transfusion
Use of Blood packed cells during hospitalization, dichotomies scale - yes or no
hospital admission
Number of hospital admission days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05448456
Brief Title
Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail
Official Title
Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
August 22, 2023 (Actual)
Study Completion Date
July 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Ashdod Hospital
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
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.
Detailed Description
Vaginal delivery is often characterized by excessive blood loss. Normal range of blood loss in uncomplicated vaginal delivery is up to 500 ml. Despite this, most women can adapt due to hemodynamic changes that occur during pregnancy Several factors during labor can promote major blood loss that may be defined as post-partum hemorrhage (PPH) Early PPH (E-PPH) is defined by the World Health Organization as "blood loss from the birth canal in excess of 500 ml during the first 24 hours after delivery E-PPH occurs in up to 6% of births and it is one of the main causes of maternal morbidity and mortality accounting for about 25% of maternal deaths worldwide Among morbidities, E-PPH can lead to post-partum anemia (PPA). PPA incidence is estimated between 50%-80% of women PPA is defined as level of hemoglobin (Hb) of 11 gr/dl one week after delivery Anemia is associated with fatigue, post-partum depression and is a significant health problem in women during the reproductive age .
One of the major causes of E-PPH is perineal trauma. Perineal trauma is present in up to 85% of births either due to an episiotomy or spontaneous tear or a combination of them both During the the second stage of labor, the midwife or the obstetrician may need to make a surgical incision (episiotomy) to increase the diameter of the vaginal outlet and facilitate the baby's birth This procedure is done with scissors or scalpel and requires repair by suturing (14). In the United States, episiotomy rate was 11.6% in 2012 In a study published by Alvarez et al in 2017, the average reduction in Hb was 1.46 ± 1.09 g/dl following vaginal delivery with a second degree tear but without an episiotomy and 2.07 ± 1.24 following vaginal delivery with an episiotomy and no perineal tear. The greatest reduction in Hb occurred among women with episiotomy and a third or fourth degree tear with a decrease of 3.1 ± 1.32 g/dl.
Different strategies have been described for preventing and treatment PPH, including active management of the third stage of labor, among them uterine massage and controlled cord traction in addition to oxytocin and the use of Tranexamic acid (TA) as PPH treatment Tranexamic acid (TA) is a lysine analog, which acts as an antifibrinolytic via competitive inhibition to the binding of plasmin and plasminogen to fibrin. TA reaches peak plasma concentration immediately after intravenous administration A meta-analysis evaluated the use of tranexamic acid after vaginal delivery for prevention of primary PPH. When used as prophylaxis within 10 min after vaginal delivery usually at the dose of 1 g IV, in addition to standard prophylaxis with oxytocin, tranexamic acid reduced the risk of primary PPH and the mean post-partum blood loss However there are no studies that evaluated the impact of TA on blood loss after vaginal deliveries with an episiotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episiotomy Wound, Anemia, Early Postpartum Hemorrhage, Hemoglobin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hexakakapron group
Arm Type
Active Comparator
Arm Description
women with an episiotomy after vaginal delivery
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
women with an episiotomy after vaginal delivery
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Hexakapron
Intervention Description
1 gram of tranexamic acid in 100 ml of 0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
100 ml of 0.9% normal saline
Primary Outcome Measure Information:
Title
Delta Hb levels
Description
Delta-Hb (Hb level prior delivery - Hb levels 24 h after birth)
Time Frame
24 hours from delivery
Secondary Outcome Measure Information:
Title
PPH rate
Description
early post partum hemorrhage
Time Frame
24 hours from delivery
Title
Uterotonics use
Description
Use of additional uterotonics drugs(other than oxytocin)- dichotomies scale, yes or no
Time Frame
24 hours from delivery
Title
Blood transfusion
Description
Use of Blood packed cells during hospitalization, dichotomies scale - yes or no
Time Frame
72 hours from delivery
Title
hospital admission
Description
Number of hospital admission days
Time Frame
120 hours from delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women aged 18-45
37-42 weeks gestation
Singleton pregnancy
Cephalic presentation
Exclusion Criteria:
Any contra-indication for vaginal birth
PPH risk factors
Dysfunctional labor
Over distended uterus (macrosomia ,Polyhydramnios,multiple gestation)
Grand multiparity
Chorioamnionitis
Precipitous labor
Operative delivery
Prolonged second stage
Previous pph
Preeclampsia
Placental abruption
Previous cesarean delivery
Thrombophilia or coagulopathy
Allergy to TA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atara De Porto Amrany, MD
Phone
+97556624055
Email
atarad@assuta.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Barzilay, Md PhD
Phone
+97233968985
Email
eranb@assuta.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atara De Porto Amrany, MD
Organizational Affiliation
Samson Assuta Ashdod University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta ashdod
City
Ashdod
State/Province
Shfela
ZIP/Postal Code
7712302
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atara De porto
Phone
556624055
Ext
972
Email
ataradp@gmail.com
First Name & Middle Initial & Last Name & Degree
Elad Proiss
Phone
45228700
Ext
972
Email
eladpreuss@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10975484
Citation
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.
Results Reference
background
PubMed Identifier
23871950
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.
Results Reference
background
PubMed Identifier
20809871
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.
Results Reference
background
PubMed Identifier
19461428
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.
Results Reference
background
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Use of Tranexamic Acid After Vaginal Delivery With Episiotomy a RCT Placebo Control Trail
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