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Completed

NCT Number: NCT02672891

Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the management of postpartum hemorrhage involve a stepwise approach including the exclusion of retained products and genital tract trauma. Uterine atony, which is the most common cause, is dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced to arrest the bleeding is the uterine tamponade using various balloons and catheters. The condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shebin Elkom, Menoufia, 11111, Egypt

About this study

Objectives: To evaluate the outcome of uterine balloon tamponade using condom-catheter in the management of primary postpartum hemorrhage (PPH).

Material and Methods: Prospective observational study included 50 women with primary postpartum hemorrhage unresponsive to uterotonics and bimanual compression, was conducted at the department of Obstetrics &Gynecology, Menoufia University Hospital, Egypt. Clinical assessment, laboratory investigations and intrauterine condom catheter were applied to all patients. The primary outcome was the success of the balloon to stop bleeding, maternal complications were assessed as secondary outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with primary postpartum hemorrhage ( defined as >500 ml estimated blood loss after vaginal delivery or >1000 ml after cesarean delivery)in the first 24 h , unresponsive to uterotonics and bimanual compression were enrolled

Exclusion criteria

  • Patients with traumatic PPH, retained placenta, coagulopathy and severe systemic diseases were excluded from the study

Treatment and study plan

condom balloon catheter

Device

The condom balloon catheters were inserted into the uterine cavity digitally or with forceps .Tight vaginal pack was inserted or cervical stitch was done to prevent displacement of the balloon catheter.

(2)-Insertion at Cesarean Section: The catheter was inserted through the uterine incision (pushing the tip to the fundus and the drainage port through the cervix into the vagina) or transvaginally and inflated after the uterine incision was closed.

Primary outcomes

  1. control uterine bleeding (normal lochia).

    Time frame: 30 minutes

Secondary outcomes

  1. Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)

    Time frame: 24 hours

  2. Maternal complications (admission to intensive care unit (ICU))

    Time frame: 24 hours

  3. Maternal complications (mortality)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Menoufia Obstetrics and Gynecology Group

Other

Registry information

Official study title

Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage in a Low Resource Setting

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2016
Registry last updated
Feb 3, 2016

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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