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Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section

Primary Purpose

Cesarean Section Complications

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
TA
placebo to misoprostol
placebo to TA
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with a multiple term pregnancy undergoing elective cesarean section

Exclusion Criteria:

  • single gestation
  • placenta praevia and placental abruption
  • undergoing cesarean section with general anesthesia
  • women undergoing cesarean section at less than 37 weeks of gestation
  • with a severe medical disorder
  • allergy to tranexamic acid or misoprostol

Sites / Locations

  • Aswan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Misoprostol with TA

Misoprostol with placebo to TA

placebo to Misoprostol with placebo to TA

Arm Description

400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout

400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout

placebo to misoprostol plus placebo to tranexamic acid

Outcomes

Primary Outcome Measures

estimation of intraoperative blood loss (ml)
measure Intraoperative blood loss in ml by gravimetric methods

Secondary Outcome Measures

amount of postoperative blood loss
measure amount of blood loss post operative in ml by gravimetric methods
number of patient with postpartum hemorrhage
calculation of the number of the patients with blood loss >1000 ml

Full Information

First Posted
December 12, 2018
Last Updated
February 14, 2019
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03774524
Brief Title
Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section
Official Title
Effects of Co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on Prevention of Postpartum Hemorrhage in Pregnant Women With Twin Pregnancy Undergoing Elective Cesarean Section: A Double-Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.
Detailed Description
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy. With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Double-Blind Randomized Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
a double-blinded randomized placebo-controlled trial
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol with TA
Arm Type
Active Comparator
Arm Description
400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout
Arm Title
Misoprostol with placebo to TA
Arm Type
Active Comparator
Arm Description
400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout
Arm Title
placebo to Misoprostol with placebo to TA
Arm Type
Placebo Comparator
Arm Description
placebo to misoprostol plus placebo to tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Active Comparator
Intervention Description
400 μg of sublingual misoprostol
Intervention Type
Drug
Intervention Name(s)
TA
Other Intervention Name(s)
Active Comparator
Intervention Description
1 gm of tranexamic acid in 100 ml saline iv
Intervention Type
Drug
Intervention Name(s)
placebo to misoprostol
Other Intervention Name(s)
Placebo comparator
Intervention Description
placebo tablets to misoprostol subligual
Intervention Type
Drug
Intervention Name(s)
placebo to TA
Other Intervention Name(s)
placebo comparator
Intervention Description
110 ml saline iv
Primary Outcome Measure Information:
Title
estimation of intraoperative blood loss (ml)
Description
measure Intraoperative blood loss in ml by gravimetric methods
Time Frame
during the operation
Secondary Outcome Measure Information:
Title
amount of postoperative blood loss
Description
measure amount of blood loss post operative in ml by gravimetric methods
Time Frame
6 hours post operative
Title
number of patient with postpartum hemorrhage
Description
calculation of the number of the patients with blood loss >1000 ml
Time Frame
24 hours post operative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with a multiple term pregnancy undergoing elective cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with a multiple term pregnancy undergoing elective cesarean section Exclusion Criteria: single gestation placenta praevia and placental abruption undergoing cesarean section with general anesthesia women undergoing cesarean section at less than 37 weeks of gestation with a severe medical disorder allergy to tranexamic acid or misoprostol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
Phone
01022336052
Ext
002
Email
hany.farouk@aswu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.ed.eg
First Name & Middle Initial & Last Name & Degree
Nahla w Shady, md
Phone
1019240504
Ext
002
Email
nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section

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