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Trial registered on ANZCTR


Registration number
ACTRN12609000372280
Ethics application status
Approved
Date submitted
23/04/2009
Date registered
27/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
uterine massage to reduce postpartum hemorrhage in women expected to deliver normally: A randomised trial
Scientific title
Uterine massage to reduce postpartum hemorrhage in women expected to deliver normally: A randomised trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
third stage of labour 4650 0
postpartum hemorrhage 4651 0
reduction of postpartum hemorrhage in women expected to deliver normally. 4757 0
Condition category
Condition code
Reproductive Health and Childbirth 4954 4954 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before delivery of the placenta, uterine massage will be done till the uterus gets contracted and do controlled cord traction. After delivery of the placenta, massage is done every 10 minutes for 30 minutes.
Intervention code [1] 4415 0
Prevention
Comparator / control treatment
oxytocin; dose 10 IU once as Intramuscular injection.
Control group
Active

Outcomes
Primary outcome [1] 5801 0
Blood loss >300ml within 30 minutes. It is measured using calibrated plastic drape placed under the buttocks of the woman.
Timepoint [1] 5801 0
30 minutes after delivery of the placenta
Primary outcome [2] 5802 0
Placenta delivered >30 minutes after birth.
Timepoint [2] 5802 0
30 minutes after birth
Secondary outcome [1] 241798 0
Blood loss 500 ml in 30 minutes (blood loss will be measured for 30 minutes). It is measured using calibrated plastic drape placed under the buttocks of the woman
Timepoint [1] 241798 0
Blood loss is measured for 30 minutes after birth
Secondary outcome [2] 241799 0
Median time to placental delivery/ placenta undelivered after 30 minutes.
Timepoint [2] 241799 0
30 minutes after birth
Secondary outcome [3] 241800 0
Use of additional uterotonics or other procedures for management of postpartum hemorrhage. Number of women who needed additional uterotonics after procedrue.
Timepoint [3] 241800 0
untill uterus becomes contracted.
Secondary outcome [4] 241801 0
Haemoglobin level after 12-24 hours < 8g/100ml. it is assessed by laboratory methods.
Timepoint [4] 241801 0
24 hours after birth
Secondary outcome [5] 241802 0
Blood transfusion. Number of women requiring blood transfusion.
Timepoint [5] 241802 0
before discharge
Secondary outcome [6] 241803 0
Maternal morbidity. Number of women admitted to intensive care unit(ICU) or with prolonged hospital stay or developed complications.
Timepoint [6] 241803 0
before discharge

Eligibility
Key inclusion criteria
Pregnant women expected to deliver normally will be given information about the study and be invited to participate.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
medical complications such as hypertension and diabetes; previous caesarian section; abdominal wall not thin enough to allow easy palpation of the uterus after delivery.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated allocation sequence.Closed opaque envelops to ensure allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1737 0
Egypt
State/province [1] 1737 0
Country [2] 1738 0
South Africa
State/province [2] 1738 0

Funding & Sponsors
Funding source category [1] 4831 0
Self funded/Unfunded
Name [1] 4831 0
Address [1] 4831 0
Country [1] 4831 0
Egypt
Primary sponsor type
University
Name
Assiut University
Address
Assiut, Arab Republic of Egypt. Post office Box 71511.
Country
Egypt
Secondary sponsor category [1] 4372 0
None
Name [1] 4372 0
Address [1] 4372 0
Country [1] 4372 0
Other collaborator category [1] 650 0
Individual
Name [1] 650 0
Professor Hany Abdel-Aleem
Address [1] 650 0
Women health center, Department of Obstetrics and Gynecology, assiut university, Assiut Arab republic of Egypt Post office: 71511
Country [1] 650 0
Egypt
Other collaborator category [2] 651 0
Individual
Name [2] 651 0
Professor Justus Hofmeyr
Address [2] 651 0
Frere Hospital,
5201,
East London
Country [2] 651 0
South Africa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6890 0
Ethics committee ,Faculty of Medicine,Assiut University
Ethics committee address [1] 6890 0
Assiut University, faculty of medicine, Assiut, Arab republic of Egypt. Postal code: 71511
Ethics committee country [1] 6890 0
Egypt
Date submitted for ethics approval [1] 6890 0
Approval date [1] 6890 0
23/02/2009
Ethics approval number [1] 6890 0
Ethics committee name [2] 6891 0
Region C-Ethics Committee,Department of Health of the Eastren Cape
Ethics committee address [2] 6891 0
PO Box 12882
Amalinda
5252
Ethics committee country [2] 6891 0
South Africa
Date submitted for ethics approval [2] 6891 0
Approval date [2] 6891 0
29/03/2005
Ethics approval number [2] 6891 0

Summary
Brief summary
Bleeding from the genital tract after childbirth (postpartum haemorrhage) is a major cause of maternal mortality and disability in under-resourced areas with poor access to health services. It is the leading cause of maternal mortality in Sub-Saharan Africa and Egypt and yet is largely preventable. In these settings, poor nutrition, malaria and anaemia add to the health risk. Heavy bleeding directly following childbirth or within 24 hours is most common. Possible causes are the uterus failing to contract after delivery (uterine atony), a retained placenta, inverted or ruptured uterus, and cervical, vaginal, or perineal lacerations.

In well-resourced settings haemorrhage is reduced by routine active management of delivery of the placenta, the third stage of labour.

Facilities for resuscitation, blood transfusion and surgical interventions are also available. The 2004 joint statement of the International Confederation of Midwives and the International Federation of Gynaecologists and Obstetricians recommends routine massage of the uterus after delivery of the placenta to promote contraction. This involves placing a hand on the woman's lower abdomen and stimulating the uterus by repetitive massaging or squeezing movements to stimulate uterine contraction.

This trials aime to evaluate the effect of uterine massage before delivery of the placenta on the blood loss after delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29524 0
Address 29524 0
Country 29524 0
Phone 29524 0
Fax 29524 0
Email 29524 0
Contact person for public queries
Name 12771 0
Hany Abdel-Aleem
Address 12771 0
Women' Health Centre, Assiut University, Assiut,Egypt. Postal code; 71511
Country 12771 0
Egypt
Phone 12771 0
002088 2414672
Fax 12771 0
002088 2373899
Email 12771 0
haleem@aun.edu.eg
Contact person for scientific queries
Name 3699 0
Hany Abdel-Aleem
Address 3699 0
Department of Obstetrics and Gynecology
Women' Health Centre
71511, Assiut, Egypt.
Country 3699 0
Egypt
Phone 3699 0
002088 2414672
Fax 3699 0
002088 2373899
Email 3699 0
haleem@aun.edu.eg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary