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Trial record 30 of 36 for:    AMINOCAPROIC ACID

Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03710304
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:

Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries.

The risk of PPH is much higher for women undergoing cesarean delivery (CD). In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth.

The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of PPH in low-resource countries.

Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety.

Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period.

Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer.

Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CD has not been investigated as much.

The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration.

Tranexamic acid(TA) is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analog; ε-aminocaproic acid.

The aim of this study was to compare the effectiveness of combined buccal misoprostol and intravenous TA with intravenous oxytocin for the prevention of PPH in patients with risk factors during cesarean section.


Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: Oxytocin Drug: Tranexamic acid plus misoprostol Drug: misoprostol Not Applicable

Detailed Description:

Eligible and consenting participants were randomized via a computer-generated random number sequence into one of two groups: one group received a pre-prepared sealed and opaque packet containing 400 μg of misoprostol (2 tablets of 200 μg), 2 ampoules of TA (1 gm for infusion) and separate placebo ampoule (distilled water). The other group received similar packets containing two placebo tablets, two placebo ampoules (distilled water) and separate 2 ampoules of oxytocin (10 IU in each ampoule for infusion) for slow intravenous injection. The misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of oxytocin will be also similar to placebo. Randomization was done by the investigator immediately before transfer to the theater, whereas the preparation of packets and confidential record maintenance was done by the labor room nursing staff.

Study drug administration 400 μg misoprostol (2 tablets of 200 μg) or two placebo tablets were given buccally after spinal anesthesia and few minutes before skin incision; then 1 gm TA or separate placebo will be diluted in 100 mL normal saline and administered slowly (over 30-60 s) intravenously before skin incision, in group 2 20 IU oxytocin or placebo ampoules in 500 mL of intravenous solution infusion over 15 min after delivery of baby.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

participants will be randomized via a computer-generated random number sequence into one of two groups: one group received a pre-prepared sealed and opaque packet containing 400 μg of misoprostol (2 tablets of 200 μg), 2 ampoules of TA (1 gm for infusion) and separate placebo ampoule (distilled water). The other group received similar packets containing two placebo tablets, two placebo ampoules (distilled water) and separate 2 ampoules of oxytocin (syntocinon; 10 IU in each ampoule for infusion) for slow intravenous injection. The misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of oxytocin was also similar to placebo. Randomization was done by the resident doctors immediately before transfer to theater, whereas preparation of packets and confidential record maintenance was done by the labor room nursing staff.

Study drug administration

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: The Effect of IV Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery: a Randomized Controlled Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: oxytocin
20 IU oxytocin ampoules in 500 mL of intravenous solution infusion over 15 min after delivery of the baby.plus 2tab placebo buccal(ranitidine) plus 110 ml saline iv
Drug: Oxytocin
20 IU oxytocin or placebo ampoules in 500 mL of intravenous solution infusion over 15 min after delivery of the baby.plus 2tab placebo buccal plus 110 ml saline by slow infusion
Other Name: Active Comparator

Active Comparator: Tranexamic acid plus misoprostol
400 μg misoprostol (2 tablets of 200 μg) or two placebo tablets were given buccally after spinal anesthesia and few minutes before skin incision; then 1 gm TA will be diluted in 100 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist before skin incision, plus 500 ml normal saline intravenous solution infusion over 15 min after delivery of the baby
Drug: Tranexamic acid plus misoprostol
1 gm TA or separate placebo will be diluted in 100 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist before skin incision,
Other Name: Active Comparator

Drug: misoprostol
400 μg misoprostol (2 tablets of 200 μg) will be give buccally after spinal anesthesia and few minutes before skin incision;
Other Name: Active Comparator




Primary Outcome Measures :
  1. number of participant required of additional pharmacological uterotonic. [ Time Frame: 24 hours post operative ]
    the number of participant need for extra uterotonic drug


Secondary Outcome Measures :
  1. difference between preoperative and postoperative hemoglobin [ Time Frame: 24 hours post operative ]
    compare of hemoglobin in gm/dl preoperative and 24 hours post operative

  2. intraoperative blood loss [ Time Frame: during the operation ]
    amount of blood loss during the operation

  3. post operative blood loss [ Time Frame: 24 hours post operative ]
    amount of blood loss from the end of operation till 24 hours post operative



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients scheduled for an elective cd with risk factors for atonic PPH during cesarean section
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for an elective cesarean section with risk factors for atonic PPH

Exclusion Criteria:

  • Patients with a cardiac, hepatic, renal or thromboembolic disease
  • patients had an allergy to tranexamic acid
  • suspected coagulopathy
  • history of coronary artery disease or hypertension
  • patient refuses to participate

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): NCT03710304


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03710304     History of Changes
Other Study ID Numbers: aswu/173/7/18
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
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:
cesarean section
tranexamic acid
postpartum hemorrhage
buccal misoprostol
Additional relevant MeSH terms:
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Tranexamic Acid
Hemorrhage
Pathologic Processes
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants