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Bakri Balloon in Placenta Previa (BB-ATS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02694341
Recruitment Status : Withdrawn (No participants shared)
First Posted : February 29, 2016
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.

Condition or disease Intervention/treatment Phase
Bleeding Placenta Previa Procedure: Abdominal traction stitch Device: Bakri Balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Bakri Balloon with abdominal traction stitch
bakri balloon will be inserted with abdominal traction stitch
Procedure: Abdominal traction stitch
Abdominal traction stitch to prevent prolapse of the Bakri balloon. A suture is tied through the uterine end shaft hole of the Bakri balloon. The other end of the suture is placed through the uterine wall. The balloon is positioned in the lower segment.The abdominal traction stitch is held by forceps and fixed, with cephalad traction applied continuously to the balloon, preventing balloon prolapse.The abdominal traction stitch is fixed by an umbilical cord clamp on the abdominal wall, preventing the suture from receding into the abdominal cavity, and, thus, maintaining the correct position of the balloon and preventing prolapse. Removal of the balloon is easy, with no resistance; the suture does not hinder balloon removal. At the time of balloon removal, the suture that was placed through the abdominal wall will traverse the intra-abdominal and intrauterine cavities, and should be kept clean.

Device: Bakri Balloon
uterine compression balloon

Experimental: Bakri Balloon without abdominal traction stitch
bakri balloon will be inserted with no performance of abdominal traction stitch
Device: Bakri Balloon
uterine compression balloon




Primary Outcome Measures :
  1. Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon. [ Time Frame: 24 hours ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All women delivered and presented with primary atonic PPH
  2. Women who accepted to participate

Exclusion Criteria:

  1. Traumatic PPH as excluded by examination under anesthesia.
  2. With any suspected or clinical evidence of uterine infection
  3. Women diagnosed to have preeclampsia or eclampsia after delivery.
  4. Women who had DM during pregnancy
  5. Women with history of DVT or other thromboembolic complication
  6. Women with history of rheumatic heart disease.
  7. Women with coagulation defects.

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): NCT02694341


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02694341    
Other Study ID Numbers: BB
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Ahmed Mohamed Abbas, Assiut University:
Management
Additional relevant MeSH terms:
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Placenta Previa
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases