Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

Sohag University

Status: Not yet enrolling

Conditions: High Risk Pregnancy; Atonic Postpartum Hemorrhage

Treatments: Drug: Carbetocin; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05479357

Soh-Med-22-07-02

Details and patient eligibility

About

Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.

Full description

Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously.

The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:

  1. History of postpartum hemorrhage.
  2. Delivery of a macrosomic baby (> 4000 g).
  3. Multiple gestation.
  4. Polyhydramnios.
  5. Grand Multiparity.
  6. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)
  7. Chorioamnionitis.

Exclusion criteria

• • Patients without high risk for post-partum hemorrhage.

  • Patients at high risk for postpartum hemorrhage but will deliver vaginally.
  • Patients with medical disorders complicating pregnancy.
  • Patients with coagulation defects.
  • Preterm pregnancies.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Oxytocin

Active Comparator group

Description:

the control group will be given 10 iu intravenously.

Treatment:

Drug: Oxytocin

Carbetocin

Active Comparator group

Description:

the treatment group will be given 100 microgram intravenously.

Treatment:

Drug: Carbetocin