The Foley's Catheter Balloon to the Bleeding From Placenta Previa
Use of Foley's Catheter Balloon Tamponade to Control Placental Site Bleeding Resulting From Placenta Previa During Cesarean Section
1 other identifier
interventional
15
1 country
1
Brief Summary
Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality . Hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. Uterine packing considers as a line of treatment before performing surgical procedures in postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid laparotomy and save uterus. Nowadays, the use of intrauterine balloons have been developed and become effective for the control of placental site bleeding not responding to medical treatment. The 2-way Foley's Cather has many advantages over the gauze packing; First, it allows drainage of blood so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way Foley's Cather could be gradually as a test of its effectiveness before complete removal .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 29, 2015
CompletedOctober 8, 2020
October 1, 2020
5 months
December 23, 2015
October 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of blood loss (mL)
6 months
Study Arms (1)
Foley's cather tamponade
EXPERIMENTALBalloon tamponade with 2-way Foley's Cather was successfully used during cesarean section due to sever postpartum haemorrhage after failure of medical treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with placenta previa
- Delivered by cesarean section
You may not qualify if:
- Patients with sever uncontrolled uterine bleeding after delivery
- Placenta accreta
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, 71111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 23, 2015
First Posted
December 29, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
October 8, 2020
Record last verified: 2020-10