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OpenTrials
Completed

NCT Number: NCT02640885

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

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 .

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with placenta previa
  • Delivered by cesarean section

Exclusion criteria

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

Treatment and study plan

Foley's cather ballon

Device

Primary outcomes

  1. Amount of blood loss (mL)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 29, 2015
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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