Postpartum Hemorrhage (Primary) Clinical Trial
Official title:
Heat Stable Carbetocin Versus Oxytocin for the Prevention of Primary Postpartum Hemorrhage in Emergency Caesarean Delivery
Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and
low-income countries, including Iraq. Much advancement had been made in the field of
treatment for postpartum haemorrhage but no much progress had been made in the field of
prevention, where one of its main component is the administration of uterotonic, preferably
oxytocin, immediately after birth of the baby.
In many low- and middle income countries, the efficacy of oxytocin cannot be assured since
access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine
degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to
Moisture.
Innovation in the manufacture of carbetocin had meet the stability requirements for hot and
humid climates.
This study had been accomplished to evaluate the uterotonic effect of carbetocin compared
with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery.
Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional
uterotonic agents or the occurrence of PPH.
Setting and design:
It is a double blinded randomized parallel clinical trial. That had been conducted at Al
Elweyia Maternity Teaching Hospital in Baghdad during the period from Jan., 4th, 2018 to
August, 1st, 2018. Written consent was insured for all the participants.
Data collection:
Three hundred and twenty pregnant women who were underwent emergency caesarean sections under
regional anesthesia were enrolled in the study (due to limitation of carbetocin ampoules that
were available). Those women were randomized to oxytocin or carbetocin in a rate of 2:1 (for
prophylaxis of PPH in the active management of third stage of labour). Twenty cases were
omitted since they were not fulfilled the eligibility criteria and only three hundred women
were completed the study. They were divided into two groups:
Group1 (case group): 100 pregnant women, whom they received carbetocin for the prevention of
PPH.
Group 2 (control group): 200 pregnant women, whom they received oxytocin for the prevention
of PPH.
Additional information including age, parity, past medical history, and body mass index (BMI)
were taken.
Intervention:
The following steps were followed:
1. Hemoglobin and hematocrit were assessed before caesarean section.
2. One ml of either carbitocin (100 mcg) or oxytocin (10 IU) was given as a bolus
intravenous injection by the anesthesiologist after labor of the baby at once.
3. The placentae were delivered by controlled cord traction.
4. It was the operating obstetrician decision to evaluated the uterine tone, bleeding
intra-operatively and the need for an additional uterotonic and method of its
administration, dose and duration.
5. Our center usual regimen for uterine atony is an oxytocin (40 IU in 500 ml isotonic
crystalloid solution) intravenous infusion over 4-5 hours.
Follow up:
For 24 hours was done, that is include:
1. Evaluation of blood loss by the obstetrician and the anesthesiologist after skin
closure, that is include the entire amount that had been suctioned, taken by the
surgical gauzes or spilled in the surgical field, using visual estimation chart for
assessment of blood loss.
2. The need of any additional uterotonic drugs after the operation was recorded.
3. The need of blood transfusion post delivery.
4. The blood pressure and pulse rate of the women involved in the study were documented at
0, 5, 10, 20, 30 and 60 minutes after the injection of the drug.
5. The period of operation (skin cut into the final closure of the skin) was recorded.
6. Intravenous fluid infusion was administered regularly and as it had been stated by the
obstetricians and maintained after the operation until oral intake was started.
7. Hemoglobin and hematocrit was assessed the day after the caesarean section.
Statistical analysis:
Statistical Package for Social Sciences (SPSS) version 21 was used. Descriptive statistics
presented as (mean ± standard deviation) and frequencies as percentages. The database was
examined for errors using range and logical data cleaning methods, and inconsistencies were
remedied. Chi square test was used to compare between categorical variables (Fishers exact
test used when expected variable was less than 20% of total) and t-test was used to compare
between two means. Cohen's d, a standardized measure of effect size for difference between 2
means, which can be compared across different variables and studies, since it has no unit of
measurement was used. Significance level was set at P < 0.05.
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