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Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

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ClinicalTrials.gov Identifier: NCT03741114
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.

The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.


Condition or disease Intervention/treatment Phase
Placenta Previa Procedure: Foley's Catheter Drug: TA Drug: Placebo Not Applicable

Detailed Description:
Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
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 was used.
Primary Purpose: Prevention
Official Title: Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Foley's Catheter plus TA
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision
Procedure: Foley's Catheter
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
Other Name: Active Comparator

Drug: TA
patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
Other Name: active comparator

Active Comparator: Foley's Catheter plus placebo to TA
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision
Procedure: Foley's Catheter
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
Other Name: Active Comparator

Drug: Placebo
patients received 100 ml saline just before skin incision
Other Name: Placebo to TA




Primary Outcome Measures :
  1. Number of Participants with postpartum hemorrhage [ Time Frame: 24 hours post operative ]
    number of participant with blood loss > 1000ml


Secondary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: during the operation ]
    amount of blood loss during cesarean section

  2. The number of participant needed for blood transfusion [ Time Frame: 24 hours postoperative ]
    Calculation of the number of participant needed for blood transfusion

  3. number of participant need of extra surgical maneuvers [ Time Frame: 24 hours post operative ]
    number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa

Exclusion Criteria:

  • Patients with a cardiac, hepatic, renal or thromboembolic disease
  • patients with the high possibility of the morbid adherent placenta
  • known coagulopathy or thromboembolic disease
  • those presented with severe antepartum hemorrhage
  • hypersensitivity or contraindications of use of tranexamic acid
  • patient refuses 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): NCT03741114


Contacts
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Contact: hany f sallam, md 01022336052 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   
Contact: Nahla w Shady, m    1019240504 ext 002    nahla.elsayed@aswu.edu.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: NCT03741114     History of Changes
Other Study ID Numbers: aswu/199/18
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
placenta previa
tranexamic acid
cesarean section
Foley's Catheter Balloon

Additional relevant MeSH terms:
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Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants