Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery

NCT ID: NCT03755531

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2018-08-01

Brief Summary

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.

Detailed Description

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.

Conditions

Postpartum Hemorrhage (Primary)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Carbetocin

One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once.

Group Type: EXPERIMENTAL

Carbetocin

Intervention Type: DRUG

Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given.

Drug was kept in cold storage (2 to 8°C).

Oxytocin

One ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly.

Drug was kept in cold storage (2 to 8°C).

Interventions

Carbetocin

Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given.

Drug was kept in cold storage (2 to 8°C).

Intervention Type: DRUG

Oxytocin

Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly.

Drug was kept in cold storage (2 to 8°C).

Intervention Type: DRUG

Other Intervention Names

BABAL; Pitocin

Eligibility Criteria

Inclusion Criteria

• Patients age ≥18 years
• Singleton pregnancy
• Full term gestation
• Emergency cesarean section during labor

Exclusion Criteria

• Cases of coagulopathy
• Drug hypersensitivity
• Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases
• Uterine fibroids
• Suspected placental pathology (accreta, previa or abruptio)
• General anesthesia
• Longitudinal uterine incision

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Elweyia Maternity Teaching Hospital

OTHER

Sponsor Role: collaborator

Al-Kindy College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Taghreed Alhaidari

Assistant Professor / Consultant Obstetrician & Gynecologist / Head of Scientific Affairs Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taghreed K Alhaidari, CABOG

Role: STUDY_CHAIR

Al Kindy College of Medicine, University of Baghdad

Shayma S Al-Zubaidy, FICOG, MD

Role: PRINCIPAL_INVESTIGATOR

Al- Elweyia Maternity Teaching Hospital

Alaa A Hussein, FICOG, MD

Role: PRINCIPAL_INVESTIGATOR

Al- Elweyia Maternity Teaching Hospital

Ulfat M Alnakkash, CABOG

Role: PRINCIPAL_INVESTIGATOR

Al- Elweyia Maternity Teaching Hospital

Ahmed S Alnuaimi, PhD

Role: PRINCIPAL_INVESTIGATOR

Baghdad College of Medicine/ University of Baghdad

Locations

Al Kindy College of Medicine/ University of Baghdad

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

4 Al-KindyCM

Identifier Type: -

Identifier Source: org_study_id