Carbetocin Versus Misoprostol. A Retrospective Comparative Study

NCT04313218 | Completed

• 1 other identifier: OBSGYN 1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is one of the most common surgeries practiced for save delivery of the fetus, however it is not a safe route of delivery its incidence is rising especially in high and middle income countries. The major concern is that the average blood loss during cesarean delivery is 487 ml, this amount is too close to the definition of postpartum hemorrhage by WHO as loss of 500 cc of blood in the first 24 hours after delivery making control of blood loss during cesarean delivery crucial to decrease maternal morbidities.This study aim to compare the use of misoprostol to carbetocin in reducing blood loss during cesarean section in low risk patients

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• blood loss

  reduction of blood loss during cesarean section operation

  during operation

Study Arms (2)

A

recieved carbetocin 100ug iv after immediately after extraction of the fetus during cesarean section

Drug: Carbetocin

B

women who received misoprostol 600ug rectally immediately before sterilization during cesarean section

Interventions

Carbetocin DRUG

iv infusion of 100ug carbetocin after extraction of the fetus during cesarean section

Also known as: misoprostol

A

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women who underwent CS and were considered at low risk for postpartum including 1- singleton pregnancy, 2- less than previous four deliveries, 3- elective lower segment C.S, 4- C.S was done under general anesthesia 5- No medical disorders complicating pregnancy, 6- Placenta neither previa nor morbidly adherent, 7- Average amount of amniotic fluid, 8- No past history of postpartum hemorrhage and 9- No contraindications to Misopristol or Carbetocin

You may qualify if:

• parity less than 4
• unscarred uterus or previous one cesarean section
• elective C.S
• general anesthesia

You may not qualify if:

• medical disorders complicating pregnancy
• more than one C.S
• selective C.S
• Risk factors for Postpartum hemorrhage

Sponsors & Collaborators

• Port Said University hospital: lead

Study Sites (1)

Waleed Elsayed Elrefaie

Port Said, NY, 42511, Egypt

Location

MeSH Terms

Interventions

carbetocin; Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 18, 2020
• Study Start: January 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 28, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)