Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
Method: This prospective study of 25 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 25 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).All patients will be followed postpartumly for evaluation of uterine cavity and menstrual cycles
General information
Acronym
Placenta Previa Complete centralis
IRCT registration information
IRCT registration number:IRCT2014040517081N1
Registration date:2014-04-12, 1393/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Khalid Mohamed
Name of organization / entity
Benha univesity
Country
Egypt
Phone
-
Email address
dr.khalidkhader77@fmed.bu.edu.eg
Recruitment status
Recruitment complete
Funding source
self funded
Expected recruitment start date
2014-04-07, 1393/01/18
Expected recruitment end date
2014-05-31, 1393/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lower uterine compression sutures for the Treatment of Postpartum Hemorrhage due to Placenta Previa Complete centralis; prospective study
Public title
Lower uterine compression sutures for the Treatment of Postpartum Hemorrhage due to Placenta Previa Complete centralis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients had placenta previa complete centralis (25). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta previa; successful removal of the placenta
exclusion criteria: shock due to massive blood loss ,failure of successful removal of the placenta
Age
From 22 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
The Universal Trial Number
Secondary trial Id
U1111-1154-6638
Registration date
2014-03-18, 1392/12/27
Ethics committees
1
Ethics committee
Name of ethics committee
Benha faculty of medicine
Street address
ej saha street
City
Benha
Postal code
Approval date
2014-03-20, 1392/12/29
Ethics committee reference number
17081
Health conditions studied
1
Description of health condition studied
placenta previa
ICD-10 code
044.1
ICD-10 code description
Placenta praevia with haemorrhage
2
Description of health condition studied
postpartum hemorrage
ICD-10 code
072
ICD-10 code description
Postpartum haemorrhage
Primary outcomes
1
Description
treatment of postpartum hemorrage
Timepoint
at time of delivery
Method of measurement
observation
Secondary outcomes
1
Description
Normal patency of the uterine cavity
Timepoint
6 months follow up
Method of measurement
sonohysterography
Intervention groups
1
Description
. All 25 patients will have lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Obstetrics and Gynecology, Benha University Hospital
Full name of responsible person
Khalid Mohamed
Street address
el saha street -Benha city
City
Benha
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Obstetrics and Gynecology, Benha University Hospital
Full name of responsible person
Khalid Mohamed
Street address
el saha street -Benha city
City
Benha
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Obstetrics and Gynecology, Benha University Hospital
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Benha University Hospital
Full name of responsible person
Khalid Mohamed
Position
lecturer ,MD
Other areas of specialty/work
Street address
el saha street -Benha city
City
Benha
Province
---------
Postal code
13518
Phone
00
Fax
Email
dr.khalidkhader77@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Benha University Hospital
Full name of responsible person
Khalid Mohamed
Position
lecturer.MD
Other areas of specialty/work
Street address
el saha street -Benha city
City
Benha
Province
---------
Postal code
13518
Phone
00
Fax
Email
dr.khalidkhader77@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Benha University Hospital
Full name of responsible person
Khalid Mohamed
Position
lecturer,MD
Other areas of specialty/work
Street address
el saha street -Benha city
City
Benha
Province
---------
Postal code
13518
Phone
0020128
Fax
201281469651
Email
dr.khalidkhader77@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)