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Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02672891
Enrollment
50
Registered
2016-02-03
Start date
2011-05-31
Completion date
2012-09-30
Last updated
2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhage, Uterine Tamponade, Condom Catheter

Brief summary

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 .

Detailed description

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.

Interventions

DEVICEcondom balloon catheter

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.

Sponsors

Menoufia Obstetrics and Gynecology Group
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
control uterine bleeding (normal lochia).30 minutes

Secondary

MeasureTime frame
Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)24 hours
Maternal complications (admission to intensive care unit (ICU))24 hours
Maternal complications (mortality)24 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026