Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774706
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:
Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: Misoprostol Drug: Tranexamic Acid Drug: placebo to tranexamic acid Not Applicable

Detailed Description:
Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind placebo randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used
Primary Purpose: Prevention
Official Title: Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized Clinical Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Misoprostol with TA
two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv
Drug: Misoprostol
two tablets misoprostol 400 μg sublingual
Other Name: Active Comparator

Drug: Tranexamic Acid
two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline
Other Name: active comparator

Active Comparator: Misoprostol with placebo to TA
two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv
Drug: Misoprostol
two tablets misoprostol 400 μg sublingual
Other Name: Active Comparator

Drug: placebo to tranexamic acid
placebo to tranexamic acid (110 ml saline)
Other Name: Placebo




Primary Outcome Measures :
  1. number of patients develop postpartum hemorrhage [ Time Frame: 6 hours post operative ]
    calculation of number of patients develop postpartum hemorrhage


Secondary Outcome Measures :
  1. intraoperative blood loss (ml) [ Time Frame: during the operation ]
    calculation of the amount of blood loss in ml by gravimetric methods


Other Outcome Measures:
  1. postoperative blood loss (ml) [ Time Frame: 6 hours post operative ]
    calculation of the amount of blood loss in ml by gravimetric methods

  2. number of patients need blood transfusion [ Time Frame: 24 hours postoperative ]
    calculation of number of patients need blood transfusion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women who undergo elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
  • age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.

Exclusion Criteria:

  • having an underlying disease (heart, liver, kidney, pulmonary, etc.),
  • eclampsia and severe preeclampsia
  • allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
  • coagulation disorders
  • refuse or unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774706


Contacts
Layout table for location contacts
Contact: hany f sallam 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
Layout table for location information
Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Contact: Nahla w Shady, md    1019240504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: hany f sallam, md Aswan University Hospital
Layout table for additonal information
Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03774706    
Other Study ID Numbers: aswu/184/18
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by hany farouk, Aswan University Hospital:
cesarean section
tranexamic acid
misoprostol
Additional relevant MeSH terms:
Layout table for MeSH terms
Misoprostol
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics