Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section
Condition: Blood Loss, Surgical; Intrapartum Hemorrhage
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus
      misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean
      section.

      The main question it aims to answer is:

      * Is carbetocin as effective as oxytocin plus misoprostol in decreasing intraoperative blood
      loss in women undergoing planned cesarean section?

      Researchers will compare 2 groups:

        -  women receiving Oxytocin plus Misoprostol;

        -  women receiving Carbetocin as regards:

        -  estimated blood loss
    

Detailed description: 
      -  Type of Study: A randomized controlled clinical trial.

        -  Study Setting: This study will be conducted in Ain Shams University Maternity Hospital
           (ASUMH).

        -  Study duration: 6 months.

        -  Study population: Women will be recruited from outpatient antenatal clinic of ASUMH.

      Sample Size:

      104 patients will be enrolled in this study and will be divided into two groups:

        -  Group A: 52 patients will receive+ Oxytocin (20 IU IV infusion on 1000 ml of normal
           saline solution) plus misoprostol (600 micrograms rectal). ( The control group )

        -  Group B: 52 patients will receive 100 micrograms Carbetocin IV slowly. Sample size
           justification By using PASS 11 software for sample size calculation, setting power at
           80%, alpha error at 5% and after reviewing previous study results showed that the
           haemoglobin level (g/dl) postoperative to caesarean section was higher among women took
           Carbetocin than those took misoprostol (10.13 ± 0.76 versus 9.57 ± 0.95 respectively);
           based on that, a sample size of at least 90 pregnant females undergoing elective
           caesarean section divided randomly into 2 intervention groups [Carbetocin and
           misoprostol with oxytocin] (45 patients in each group) will be sufficient to achieve
           study objective, yet the drop out rate 17% so 7 patients will be added in each group.

      Procedures:

        1. Approval of the protocol by the ethical committee of the department of Obstetrics &
           Gynecology, Faculty of Medicine, Ain Shams University.

        2. Recruitment of patients planning to undergo elective cesarean section in ASUMH from
           antenatal clinic.

        3. An informed written consent will be taken from all participants before enrollment in the
           study and after explaining the purpose, possible risks and complications.

        4. All participants will be subjected to thorough history taking, general and abdominal
           examination, obstetric ultrasound examination and laboratory investigations including
           complete blood count to identify eligible patients.

        5. The expert consultant will take the decision to do the cesarean section.

        6. Eligible patients will be randomised & allocated into 2 groups (A) & (B). Randomization
           will be done using computer generated list.

        7. Allocation & concealment will be done using sealed envelopes prepared according to
           computer generated list into ratio 1:1. Patients will deliver by cesarean section.
           Patients in group A will receive 600 micrograms misoprostol rectally immediately before
           sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution
           immediately after delivery of the fetus.

        8. Patients in group B will receive 100ug Carbetocin by slow IV infusion (over one minute)
           intra-operative immediately after delivery of the fetus.

        9. Estimation of blood loss will be calculated by :

             -  After delivery of the placenta, the amount of blood loss in the suction canister
                and drapes will be measured.

             -  The equation* used when calculating blood loss of a blood-soaked item is WET Item
                Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item. The items
                are weighed using a highly accurate digital balance ( Salter digital electronic
                scale 9037 TL3R).

             -  Although a gram is a unit of mass and a milliliter is a unit of volume, the
                conversion from one to the other is a simple 1-to-1 conversion.

             -  The amniotic fluid index (AFI) was estimated using abdominal ultrasound as the sum
                of the maximum vertical diameter of amniotic fluid in four quadrants in
                centimeters.

             -  Amniotic fluid volume (AFV) (ml) was estimated by multiplying AFI (cm) by 30.

             -  At the end of the surgery, the volume of quantified blood calculated by weight will
                be added to the volume of quantified blood in the suction canister then subtracting
                the amniotic fluid volume to determine total quantification of blood loss.

       10. Follow up & data recording; • Post-partum hemorrhage will be considered:

      1. Minor PPH: if estimated blood loss from 500 ml to 1000 ml. 2. Major PPH: if any estimated
      blood loss is more than 1000 ml.

        -  Measuring hemoglobin level before & after 24 hours of delivery to asses the need for
           blood transfusion.

        -  All data will be recorded in Case Report Form.
    

Intervention name(s): Oxytocin + misoprostol; Carbetocin
Intervention type(s): Drug; Drug
Intervention description(s): 600 micrograms misoprostol rectally 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution; 100 micrograms carbetocin
Intervention MeSH terms: Misoprostol; Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: estimated blood loss; carbetocin; oxytocin; misoprostol