A comparative study of Injection Carbetocin with Injection Oxytocin for the prevention of postpartum haemorrhage.

Introduction:

Postpartum haemorrhage is defined as any blood loss >500 ml in vaginal delivery or >1000ml in c section. It can also be defined as a fall in Hematocrit by >10%

Uterine atony, till date remains the major cause of PPH.

 As a prevention for this, oxytocics have been used as uterotonics after the delivery of the baby.

WHO recommends active management of third stage of labor (AMTSL) which has four components: 1) Injecting a uterotonic to the mother after baby delivery 2) Delayed cord clamping 3) Deliver the placenta by controlled cord traction 4) Intermittent assessment of uterine tone.

 WHO in its newer recommendations has included Inj Carbetocin as an oxytocic for AMTSL.

Carbetocin works as an oxytocic, anti hemorrhagic and a uterotonic drug. Carbetocin has a much longer lasting effect as compared to oxytocin necessitating a single dose administration.

 The aim of the study is to throw some more light on the results of Carbetocin administration for prevention of PPH as not many studies have been done in India compared to he number of studies done abroad.

 AIMS AND OBJECTIVES:

PRIMARY OBJECTIVE:

To compare the efficacy of Injection Carbetocin with Injection Oxytocin for the prevention of PPH.

 SECONDARY OBJECTIVE:

To compare the safety of Injection Carbetocin with Injection Oxytocin.

 METHODOLOGY:

 TYPE OF STUDY:

A RANDOMISED CONTROL TRIAL

 STUDY SETTING:

Labor room and emergency OT at department of obstetrics and gynaecology at GMERS medical college and general hospital Gotri Vadodara. Patients presenting to the labor room of GMERS hospital Gotri Vadodara in active labor and delivering by either Vaginal delivery or c section in a period of 1 year beginning from 1/3/2023 to 1/3/2024

 STUDY PERIOD:

1 year

 STUDY PROCESS: A randomised trial will be conducted in two groups with a total of 80 patients, 40 in each group. 40 women will receive Inj Carbetocin 100 mcg IV single dose after the delivery of the placenta and 40 women will receive Inj Oxytocin 10IU IM after the delivery of the placenta.

 A comparison will be made between the incidence of PPH between women receiving Inj Carbetocin and women receiving Inj Oxytocin by measuring the amount of blood loss (>500 ml for vaginal deliveries and >1000ml in c sections) or by a decrease in hematocrit by>10

 A comparison will be made between the incidence of side effects in women receiving Inj Carbetocin and women receiving Inj Oxytocin.

 Individual side effects of each drug are:

Inj Carbetocin:

Nausea, vomiting

Abdominal pain

Increased body temperature

Trembling

Weakness

Dizziness

Chills and sweating

Chest pain

Tachycardia

Respiratory distress

 Inj Oxytocin:

Nausea , vomiting

Increased blood pressure

Cardiac arrhythmia

Anaphylaxis

Water retention

  INCLUSION CRITERIA:

1.Primigravida

2.Multigravida

3.Singleton pregnancy

4.Multiple pregnancy

5.Previous cesarean section

6.Currently undergoing normal, instrumental, C-section.

  EXCLUSION CRITERIA:

1.High blood pressure(eclampsia, pre eclampsia, gestational hypertension, chronic hypertension)

2.Cardiovascular problems

3. Known contraindications to any of the drugs.

 SAMPLE SIZE AND SAMPLING METHOD

 Sample size: 80

Formula: n0=z2 x P(1-p) /e2

N= n0 x N /n0 + (N+1)

n  = sample size of known population

n0= proportion of unknown population

N = known population size

 Type of study: Randomised control trial

Sampling method: Simple random sampling

 OUTCOME MEASURES:

1.        Number of patients developing pph after Inj Carbetocin and after Inj Oxytocin. PPH will be identified by the approximate blood loss >500ml after vaginal delivery and >1000 ml after c section or a fall in hematocrit by >10%

2.        Number of patients developing side effects ( as iterated above) of Inj Carbetocin and Inj Oxytocin.