Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000546550
Ethics application status
Approved
Date submitted
26/04/2015
Date registered
28/05/2015
Date last updated
12/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
studying the effect of different uterotonic agents in prevention of postpartum hemorrhage following cesarean section in high risk cases.
Scientific title
Comparative study between carbetocin,oxytocin and misoprostol in prevention of postpartum hemorrhage following cesarean section in high risk cases.
Secondary ID [1] 286545 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum hemorrhage following cesarean section 294783 0
Condition category
Condition code
Surgery 295300 295300 0 0
Other surgery
Reproductive Health and Childbirth 295412 295412 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
pregnant women undergoing cesarean section and at high risk to develop post partum hemorrhage.
All the patients will be subjected to the following after taking informed written consent:
1. Full history taking.
2. General examination including patient weight.
3. Abdominal examination including obstetric ultrasound.
4. Routine laboratory tests including hemoglobin and hematocrit.
5. Anesthesia technique will be standardized, spinal anesthesia will be performed. Patients will receive an intravenous bolus of 500 mL crystalloid before spinal anesthesia. A size 25G pencil-point needle will be used at a suitable lumbar inter-space. The patient can be sitting or in the left lateral position for spinal anesthesia. The anesthetic solution consisted of 2 ml 0.5% hypertonic bupivocaine (2.2 ml in the sitting position), 10–20 microgram fentanyl and 0.1 mg preservative free morphine. Anesthesia should be to the level of T5, as assessed by touch. The patient will be tilted 15 degree to the left of supine and standard monitoring used as per the AAGBI guidelines. Anesthetists will replace blood loss at operation with colloid infusion or blood when deemed necessary. Intravenous crystalloids were continued at 1 Litre every 8 hours until the morning after surgery.
6. The patients will be divided randomly in to 3 GROUPS:
* GROUP 1:80 patients will receive 100 microgram of PAPAL
(carbetocin) IV as a uterotonic agent after delivery of fetal anterior shoulder.
* GROUP 2:80 patients will receive 5 IU of IV bolus oxytocin then will be followed by 40 IU of oxytocin infusion on 1000 ml saline with a rate of 150 ml per hour as a uterotonic agent after delivery of fetal anterior shoulder.
* GROUP 3:80 patients will receive 800 microgram misoprostol rectally immediately after anesthesia and before Cesarean Section followed by 5 IU of oxytocin IV bolus immediately after delivery of anterior shoulder as a uterotonic agent.
7. Active management of the third stage of labour as the following:
* Administration of the uterotonic agent with delivery of the anterior shoulder of the baby.
* Clamping and cutting the umbilical cord soon after birth.
* Applying controlled cord tension to the umbilical cord while
applying simultaneous counter-pressure to the uterus, through the abdomen.
8. The surgical approach to cesarean section is standardized. Surgeons will be asked to operate to a standard procedure that specifies transverse lower segment ceserean section two layer closure of the uterine incision, and to avoid delivering the uterus for suturing unless clinically indicated.
9. Follow up the patients postoperative regarding vital signs and
hemoglobin and hematocrit 48 hours after surgery
Intervention code [1] 291714 0
Prevention
Intervention code [2] 291841 0
Treatment: Drugs
Comparator / control treatment
Active comparator group 2:80 patients will receive 5 IU of IV bolus oxytocin then followed by 40 IU of oxytocin infusion on 1000 ml saline with a rate of 150 ml per hour immediately after delivery of anterior shoulder as a uterotonic agent.

* Active comparator group 3:80 patients will receive 800 microgram misoprostol rectally immediately after anesthesia and before Cesarean Section followed by 5 IU of oxytocin IV bolus immediately after delivery of anterior shoulder as a uterotonic agent.
Control group
Active

Outcomes
Primary outcome [1] 295056 0
* To compare the incidence of major obstetric hemorrhage
( bleeding equal to or greater than 1000 ml following use of different uterotonic agent).

Major obstetric hemorrhage will be defined by:
1-measured blood loss as calculated from pre and postoperative haematocrit as following formula:

This estimate was based on the difference between the preoperative and postoperative packed cell volume (PCV), and is calculated as follows:

Calculated estimated blood loss is equal to estimated blood volume × (preoperative PCV - postoperative PCV)/preoperative PCV

(Where estimated blood volume is equal to booking weight (kg) × 85)

We have chosen this calculation as a quantitative objective measure to estimate hemorrhage because it is widely accepted that clinicians underestimate blood loss and that gravimetric methods include liquor in addition to blood, which limits accuracy.
Timepoint [1] 295056 0
24 hours post completion of cesarean surgery
Primary outcome [2] 295057 0
* To compare the need for an additional uterotonic agent between the three groups.

We chose the use of an additional uterotonic agent as a primary outcome because obstetricians are likely to intervene in the event of uterine atony and use an additional agent to prevent hemorrhage.
Timepoint [2] 295057 0
24 hours post completion of cesarean surgery
Primary outcome [3] 295058 0
* The need of uterine massage among the three groups.
Timepoint [3] 295058 0
24 hours after the completion of ceserean surgery.
Secondary outcome [1] 314677 0
- To compare the estimated mean operative blood loss between the two groups (as measured by theatre staff) Disposable waterproof drapes are in use with pockets that capture all body fluids. The suction volume is measured. All swabs are weighed to measure additional blood loss.
Timepoint [1] 314677 0
48 hours after ceserean surgery
Secondary outcome [2] 314678 0
- To compare the objective change in hemoglobin and hematocrit
before and 48 hours after delivery between the three groups by complete blood picture assay .
Timepoint [2] 314678 0
complete blood picture assay before delivary and 48 hours after surgery
Secondary outcome [3] 314679 0
- To compare the incidence of severe anaemia (Hb fall equal to or greater than 20%) 48 hours after delivery between the three groups by serum assay (or patient transfused) .
Timepoint [3] 314679 0
48hours after ceserean surgery
Secondary outcome [4] 314680 0
To compare the need for blood transfusion and/or blood products.
Timepoint [4] 314680 0
48 hours after ceserean surgery
Secondary outcome [5] 314681 0
- To compare the incidence of side effects (vomiting,hypotension).
Timepoint [5] 314681 0
48 hours after ceserean surgery

Eligibility
Key inclusion criteria
pregnant full term women that are scheduled to undergo ceserean section and have at least ONE of following (high risk patients for PPH) .
1. Past history of PPH.
2. Antepartum hemorrhage (eg placenta previa and accidental
hemorrhage.
3. Over distension of the uterus (polyhydraminos, multiple pregnancy and macrosomia.
4. Intra-amniotic infection.
5. Uterine muscle exhaustion (prolonged labour and high parity).
6. Anatomical uterine anomalies and uterine fibroid.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical disorders with pregnancy eg hypertensive disorder, Diabetes Mellitus, serious cardiovascular disorders, migraine ,epilepsy, asthma etc…

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2015
Actual
10/06/2015
Date of last participant enrolment
Anticipated
1/06/2016
Actual
20/07/2016
Date of last data collection
Anticipated
3/06/2016
Actual
23/07/2016
Sample size
Target
240
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 6846 0
Egypt
State/province [1] 6846 0
cairo

Funding & Sponsors
Funding source category [1] 291162 0
Self funded/Unfunded
Name [1] 291162 0
sherine hosny mohamed
Country [1] 291162 0
Egypt
Primary sponsor type
Individual
Name
Sherine Hosny Mohamed
Address
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country
Egypt
Secondary sponsor category [1] 289839 0
None
Name [1] 289839 0
NONE
Address [1] 289839 0
NONE
Country [1] 289839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292737 0
Cairo Univeristy
Ethics committee address [1] 292737 0
Ethics committee country [1] 292737 0
Egypt
Date submitted for ethics approval [1] 292737 0
Approval date [1] 292737 0
20/04/2015
Ethics approval number [1] 292737 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56594 0
Dr Sherine Hosny Mohamed
Address 56594 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country 56594 0
Egypt
Phone 56594 0
+201097665573
Fax 56594 0
Email 56594 0
[email protected] [email protected]
Contact person for public queries
Name 56595 0
Sherine Hosny Mohamed
Address 56595 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country 56595 0
Egypt
Phone 56595 0
+201097665573
Fax 56595 0
Email 56595 0
[email protected] [email protected]
Contact person for scientific queries
Name 56596 0
Sherine Hosny Mohamed
Address 56596 0
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country 56596 0
Egypt
Phone 56596 0
+201097665573
Fax 56596 0
Email 56596 0
[email protected] [email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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