NCT02672891

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
Last Updated

February 3, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

December 23, 2015

Last Update Submit

January 31, 2016

Conditions

Postpartum Hemorrhage

Keywords

Postpartum HemorrhageUterine TamponadeCondom Catheter

Outcome Measures

Primary Outcomes (1)

  • control uterine bleeding (normal lochia).

    30 minutes

Secondary Outcomes (3)

  • 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

Study Arms (1)

Device

EXPERIMENTAL

condom balloon catheter which is composed of a latex condom (SURE natural latex condom, Shanghai) and a 16-20 F, 2 ways silicon coated Foley catheter (Egypt). The catheter was introduced inside the condom and tied over tightly several times with a silk suture, to prevent air escape.

Device: condom balloon catheter

Interventions

condom balloon catheterDEVICE

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.

Device

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Shebin Elkom, Menoufia, 11111, Egypt

Location

Related Publications (2)

  • Schmidt J, Hotz HG, Foitzik T, Ryschich E, Buhr HJ, Warshaw AL, Herfarth C, Klar E. Intravenous contrast medium aggravates the impairment of pancreatic microcirculation in necrotizing pancreatitis in the rat. Ann Surg. 1995 Mar;221(3):257-64. doi: 10.1097/00000658-199503000-00007.

    PMID: 7717779RESULT

  • Kandeel M, Sanad Z, Ellakwa H, El Halaby A, Rezk M, Saif I. Management of postpartum hemorrhage with intrauterine balloon tamponade using a condom catheter in an Egyptian setting. Int J Gynaecol Obstet. 2016 Dec;135(3):272-275. doi: 10.1016/j.ijgo.2016.06.018. Epub 2016 Aug 21.

    PMID: 27599602DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hamed El Ellakwa, MD

    Menoufiya faculty of medicine,menoufiya university,ministry of higher education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2015

First Posted

February 3, 2016

Study Start

May 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 3, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

Yes

Locations

EG(1)