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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Recruitment Status : Withdrawn (No participants shared)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

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE February 29, 2016
Last Update Posted Date May 28, 2020
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon. [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bakri Balloon in Placenta Previa
Official Title  ICMJE Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Bleeding
  • Placenta Previa
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Bakri Balloon with abdominal traction stitch
    bakri balloon will be inserted with abdominal traction stitch
    Interventions:
    • Procedure: Abdominal traction stitch
    • Device: Bakri Balloon
  • Experimental: Bakri Balloon without abdominal traction stitch
    bakri balloon will be inserted with no performance of abdominal traction stitch
    Intervention: Device: Bakri Balloon
Publications * Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7:CD013663. doi: 10.1002/14651858.CD013663. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2016)
40
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02694341
Other Study ID Numbers  ICMJE BB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP