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

NCT ID: NCT02640885

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-11-30

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 .

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Foley's cather tamponade

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

Group Type: EXPERIMENTAL

Foley's cather ballon

Intervention Type: DEVICE

Interventions

Foley's cather ballon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with placenta previa
• Delivered by cesarean section

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

FCB

Identifier Type: -

Identifier Source: org_study_id