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Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT03870256
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery

Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Drug: misoprostol Drug: Carbetocin Drug: TA Not Applicable

Detailed Description:
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study was a prospective double-blind randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This study was a prospective double-blind randomized study
Primary Purpose: Treatment
Official Title: The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TA plus misoprostol
Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm
Drug: misoprostol
Patient receive 600mic gm sublingual misoprostol
Other Name: Active comparator

Drug: TA
The patient receives 1gm oral tranexamic acid
Other Name: Active Comparator

Active Comparator: Carbetocin
Patient receives 100 mic gm carbetocin IV
Drug: Carbetocin
Patient receive 100 mic gm carbetocin IV
Other Name: Active Comparator




Primary Outcome Measures :
  1. the amount of blood loss [ Time Frame: 6 hours post delivery ]
    the amount of blood loss by gm calculated by gravimetric methods


Secondary Outcome Measures :
  1. number of patients loss more than 1000 ml blood [ Time Frame: 24 hours post delivery ]
    calculate number of patients loss more than 1000 ml blood

  2. need of uterotonics [ Time Frame: 24 hours post delivery ]
    number of patients need of uterotonics



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.

Exclusion Criteria:

  • were gestational age<37 weeks,
  • genital tract trauma,
  • coagulation defect,
  • women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
  • known hypersensitivity to carbetocin or oxytocin.

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): NCT03870256


Contacts
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Contact: hany f allam, md 0102236052 ext 002 hany.farouk@aswu.edu.eg
Contact: nahla w shady, md 01092440504 ext 002 nahla.elsayed@aswu.edu.eg

Locations
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Egypt
AswanUH Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, md    00201022336052    hany.farouk@aswu.edu.eg   
Contact: Nahla w Shady, md    00101092440504    nahla.elsayed@aswu.ed.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f allam, md Aswan University Hospital

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Responsible Party: hany farouk, lecturer, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03870256     History of Changes
Other Study ID Numbers: aswu/200/19
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Postpartum Hemorrhage
vaginal delivery
tranexamic acid
misoprostol

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Misoprostol
Tranexamic Acid
Carbetocin
Oxytocin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants