Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000632493
Ethics application status
Approved
Date submitted
25/01/2016
Date registered
16/05/2016
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors associated with postpartum hemorrhage maternal morbidity and mortality in Minia Governorate hospitals
Scientific title
Factors associated with postpartum hemorrhage maternal morbidity and mortality in Minia Governorate hospitals a cross-sectional epidemiological survey
Secondary ID [1] 288406 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum hemorrhage 297417 0
Condition category
Condition code
Reproductive Health and Childbirth 297604 297604 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
all cases will deliver in Minia govern rate hospitals will be followed up for 24h for development of primary PPH ,, cases have had PPH will be followed up for maternal morbidity and mortality outcomes from onset of bleeding till control of bleeding or death .
Intervention code [1] 293719 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297152 0
Identification of factors which lead to increase PPH associated maternal mortality by review patient history , investigation and events during labor .
Timepoint [1] 297152 0
factors identified from start of labor to control of bleeding or death
Secondary outcome [1] 320172 0
factors associated with increase PPH related morbidity by review patient history , investigation and events during labor .
Timepoint [1] 320172 0
factors associated with increase PPH related morbidity by review patient history , investigation and events during labor . Time point from start of labour to control of bleeding or death .

Eligibility
Key inclusion criteria
All women will give birth in Minia governorate hospitals complicated with postpartum hemorrhage in 1st 24hours of labor.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with incomplete data collection during labor or postpartum period.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on previous studies at the same hospital, the incidence of pph was approximately 2.5%. About 10000 women give birth at the hospital every year. So the expected number if cases to be diagnosed with pph during the study period will be 300, Sample size calculation was calculated by EPi Info program depending in the type of the study which was clinical trial. Using proportion of expected outcome among treated group and among control group . Level of statistical significance power used at less than . 0.05. Level of attrition should not exceed 10-15%

the same method was used for calculation of sample size only thing that was changed is the hospital flow per year it was increased this year than it was expected to reach 12000 cases per year .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2016
Actual
9/07/2016
Date of last participant enrolment
Anticipated
13/06/2017
Actual
15/06/2017
Date of last data collection
Anticipated
Actual
22/06/2017
Sample size
Target
300
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 7552 0
Egypt
State/province [1] 7552 0
minia

Funding & Sponsors
Funding source category [1] 292760 0
Hospital
Name [1] 292760 0
maternity hospital Minia university
Country [1] 292760 0
Egypt
Primary sponsor type
Hospital
Name
maternity hospital Minia University
Address
Minia university campus , Minia university , Minia . Minia postal code 61519
Country
Egypt
Secondary sponsor category [1] 291490 0
University
Name [1] 291490 0
Minia university
Address [1] 291490 0
Minia university campus , minia university , Minia Minia postal code 61519
Country [1] 291490 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294245 0
Minia University faculty of medicine ethical committee
Ethics committee address [1] 294245 0
Faculty of medicine , Minia University campus , Minia university , Minia postcode 61519
Ethics committee country [1] 294245 0
Egypt
Date submitted for ethics approval [1] 294245 0
21/01/2016
Approval date [1] 294245 0
02/07/2016
Ethics approval number [1] 294245 0

Summary
Brief summary
This cross sectional survey study will be carried out in 12 hospitals in Minia governorate during the period from July 2016 till June 2017 after approval of ethical committee faculty of medicine
All cases of postpartum hemorrhage will be observed prospectively
Maternal morbidity and mortality related to postpartum hemorrhage will be recorded in all cases give birth in Minia governorate hospitals main objective of the study to identify factors that associated with increased maternal morbidity and mortality in cases that will develope primary PPH,study hypothesis if we can understand these factors that increase maternal complication we can avoid them for better maternal outcome

Detailed data about all cases will be recorded in the form of personal data obstetric data medical data, data related to medical service and hospital characteristics
Personal data

Obstetric data
Parity
Previous mode of delivery
Previous history of postpartum hemorrhage
Regular antenatal care of current pregnancy
Prelabour HB%
Birth weight.
Medical data
who attending delivery
5-Experience of doctor assisting delivery G P or resident or senior resident or specialist or senior specialist or consultant
6-Mangment of third stage :Active or passive
7-Time taken to diagnose postpartum hemorrhage
8-transfer-delivary interval time
9-Hospital referral One or two or managed in same hospital
10-Proceuders done Conservative or Exploration conservative surgery or hysterectomy
11- Hospital will manage postpartum hemorrhage Primary or secondary or tertiary
12-Availability of blood transfusion
13-Number of blood units and blood products units received
14-Type of morbidity
Cardiovascular dysfunction
Respiratory dysfunction
Renal dysfunction.
Hepatic dysfunction.
Coagulation dysfunction.
Neurological dysfunction.
Complications of blood transfusion
Complications related to fertility
15-I C U admission
16-Maternal mortality related to postpartum hemorrhage
objective to assess factors associated with maternal morbidity and mortality in patients with postpartum hemorrhage in Minia governorate hospitals
Trial website
Trial related presentations / publications
Public notes
This cross sectional survey study will be carried out in 12 hospitals in Minia governorate during the period from July 2016 till June 2017 after approval of ethical committee faculty of medicine
All cases of postpartum hemorrhage will be observed prospectively
Maternal morbidity and mortality related to postpartum hemorrhage will be recorded in all cases give birth in Minia governorate hospitals
Inclusion criteria
All women will give birth in Minia governorate hospitals complicated with postpartum hemorrhage in 1st 24hours of labor.
Exclusion criteria
Women with incomplete data collection during labor or postpartum period
Detailed data about all cases will be recorded in the form of personal data obstetric data medical data, data related to medical service and hospital characteristics
Personal data
Age
Residence Rural or urban
Residence Near or outside the region location of the hospital
Body mass index
Level of education Primary or secondary or tertiary
Social standard: Low or mid or high
Obstetric data
Parity
Previous mode of delivery
Previous history of postpartum hemorrhage
Regular antenatal care of current pregnancy
Prelabour HB%
Birth weight.
Medical data
Anemia
Coagulation defect
Diabets.
Renal disease.
Liver disease.
Hypertensive disorders.
Cardiac disease
Data related to medical service delivered
Place of delivery
2-Mode of delivery
3-Time of delivery Day or night
4-Who attending delivery
5-Experience of doctor assisting delivery G P or resident or senior resident or specialist or senior specialist or consultant
6-Mangment of third stage :Active or passive
7-Time taken to diagnose postpartum hemorrhage
8-transfer-delivary interval time
9-Hospital referral One or two or managed in same hospital
10-Proceuders done Conservative or Exploration conservative surgery or hysterectomy
11- Hospital will manage postpartum hemorrhage Primary or secondary or tertiary
12-Availability of blood transfusion
13-Number of blood units and blood products units received
14-Type of morbidity
Cardiovascular dysfunction
Respiratory dysfunction
Renal dysfunction.
Hepatic dysfunction.
Coagulation dysfunction.
Neurological dysfunction.
Complications of blood transfusion
Complications related to fertility
15-I C U admission
16-Maternal mortality related to postpartum hemorrhage
objective to assess factors associated with maternal morbidity and mortality in patients with postpartum hemorrhage in Minia governorate hospitals

Contacts
Principal investigator
Name 63022 0
Dr Reham Elkhateeb
Address 63022 0
Reham Elkhateeb Minia University campus , Minia University , Minia , Egypt postcode 61519
Country 63022 0
Egypt
Phone 63022 0
+201011966648
Fax 63022 0
2332666
Email 63022 0
[email protected]
Contact person for public queries
Name 63023 0
A/Prof Ahmad Sameer
Address 63023 0
Minia University campus , Minia University , Minia , Egypt postcode 61519
Country 63023 0
Egypt
Phone 63023 0
00201000222994
Fax 63023 0
2332666
Email 63023 0
[email protected]
Contact person for scientific queries
Name 63024 0
Dr Ahmad Mahran
Address 63024 0
Minia University campus , Minia University , Minia , Egypt postcode 61519
Country 63024 0
Egypt
Phone 63024 0
+201115551073
Fax 63024 0
+201251 55 3226
Email 63024 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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