Carbetocin & Oxytocin in Elective Caesarean Section With High Risk of

Status Completed

Clinical Trial Summary

Double blinded randomized controlled study

Clinical Trial Description

Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.

264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.

Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder.

Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder.

- All patients will receive general anaesthesia.

- Operation will be carried out by a three year registrar (at least).

- Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.

- Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation:

- The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit

Secondary endpoints include:

1. The need for additional uterotonic medication after carbetocin or oxytocin administration.

- Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery

- Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally.

2. The need for blood transfusion or operative interventions related to PPH

- The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered.

3. The change in hemoglobin and hematocrit post versus pre CS

- The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery.

4. The hemodynamic adverse effects and the cost-benefit of both drugs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02391636
Study type	Interventional
Source	Ghamra Military Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	February 2015
Completion date	December 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms