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

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Device: Foley's cather ballon

• Registration Number: NCT02640885
• Lead Sponsor: Assiut University

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Patients with placenta previa
• Delivered by cesarean section

Exclusion Criteria

• Patients with sever uncontrolled uterine bleeding after delivery
• Placenta accreta

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Foley's cather tamponade	Foley's cather ballon	Balloon tamponade with 2-way Foley's Cather was successfully used during cesarean section due to sever postpartum haemorrhage after failure of medical treatment.

Primary Outcome Measures

Name	Time	Method
Amount of blood loss (mL)	6 months

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt