The Foley's Catheter Balloon to the Bleeding From Placenta Previa

Postpartum Hemorrhage Clinical Trial

Official title:

Use of Foley's Catheter Balloon Tamponade to Control Placental Site Bleeding Resulting From Placenta Previa During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640885
• Other study ID #: FCB
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients with placenta previa

• Delivered by cesarean section

Exclusion Criteria:

• Patients with sever uncontrolled uterine bleeding after delivery

• Placenta accreta

Related Conditions & MeSH terms

• Hemorrhage
• Placenta Previa
• Postpartum Hemorrhage

Intervention

Device:
• Foley's cather ballon

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood loss (mL)		6 months