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Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section

Primary Purpose

Blood Loss, Surgical, Intrapartum Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Oxytocin + misoprostol
Carbetocin
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring estimated blood loss, carbetocin, oxytocin, misoprostol

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women planning to deliver by CS. Age between 18-40. Gestational age: (36-42 weeks). Exclusion Criteria: Women in active labour. Rupture of membranes more than 24 hours &/or intraamniotic infection. Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery. Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta. Major intrapartum hemorrhage more than 1000 ml. History of postpartum hemorrhage. Anemia (Hb level less than 10g/dl). Uterine overdistention eg: polyhydramnios, macrosomic baby, multiple pregnancy. Known allergy to any of misoprostol, oxytocin, carbetocin. Known medical disorders: Diabetes Mellitus, hypertensive disorders, Systemic Lupus Erythematosus. Known coagulopathy problem. Contraindication &/or refusal to spinal anesthesia.

Sites / Locations

  • Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oxytocin+Misoprostol

Carbetocin

Arm Description

Patients in this group will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus.

Patients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.

Outcomes

Primary Outcome Measures

estimated blood loss in millimeters
estimated blood lost during the cesarean section (CS)

Secondary Outcome Measures

drop in hemoglobin
Difference in Hemoglobin level before and after CS

Full Information

First Posted
December 16, 2022
Last Updated
July 21, 2023
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05664659
Brief Title
Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section
Official Title
Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Intraoperative Blood Loss in Women Undergoing Planned Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section. The main question it aims to answer is: * Is carbetocin as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section? Researchers will compare 2 groups: women receiving Oxytocin plus Misoprostol; women receiving Carbetocin as regards: estimated blood loss
Detailed Description
Type of Study: A randomized controlled clinical trial. Study Setting: This study will be conducted in Ain Shams University Maternity Hospital (ASUMH). Study duration: 6 months. Study population: Women will be recruited from outpatient antenatal clinic of ASUMH. Sample Size: 104 patients will be enrolled in this study and will be divided into two groups: Group A: 52 patients will receive+ Oxytocin (20 IU IV infusion on 1000 ml of normal saline solution) plus misoprostol (600 micrograms rectal). ( The control group ) Group B: 52 patients will receive 100 micrograms Carbetocin IV slowly. Sample size justification By using PASS 11 software for sample size calculation, setting power at 80%, alpha error at 5% and after reviewing previous study results showed that the haemoglobin level (g/dl) postoperative to caesarean section was higher among women took Carbetocin than those took misoprostol (10.13 ± 0.76 versus 9.57 ± 0.95 respectively); based on that, a sample size of at least 90 pregnant females undergoing elective caesarean section divided randomly into 2 intervention groups [Carbetocin and misoprostol with oxytocin] (45 patients in each group) will be sufficient to achieve study objective, yet the drop out rate 17% so 7 patients will be added in each group. Procedures: Approval of the protocol by the ethical committee of the department of Obstetrics & Gynecology, Faculty of Medicine, Ain Shams University. Recruitment of patients planning to undergo elective cesarean section in ASUMH from antenatal clinic. An informed written consent will be taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications. All participants will be subjected to thorough history taking, general and abdominal examination, obstetric ultrasound examination and laboratory investigations including complete blood count to identify eligible patients. The expert consultant will take the decision to do the cesarean section. Eligible patients will be randomised & allocated into 2 groups (A) & (B). Randomization will be done using computer generated list. Allocation & concealment will be done using sealed envelopes prepared according to computer generated list into ratio 1:1. Patients will deliver by cesarean section. Patients in group A will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus. Patients in group B will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus. Estimation of blood loss will be calculated by : After delivery of the placenta, the amount of blood loss in the suction canister and drapes will be measured. The equation* used when calculating blood loss of a blood-soaked item is WET Item Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item. The items are weighed using a highly accurate digital balance ( Salter digital electronic scale 9037 TL3R). Although a gram is a unit of mass and a milliliter is a unit of volume, the conversion from one to the other is a simple 1-to-1 conversion. The amniotic fluid index (AFI) was estimated using abdominal ultrasound as the sum of the maximum vertical diameter of amniotic fluid in four quadrants in centimeters. Amniotic fluid volume (AFV) (ml) was estimated by multiplying AFI (cm) by 30. At the end of the surgery, the volume of quantified blood calculated by weight will be added to the volume of quantified blood in the suction canister then subtracting the amniotic fluid volume to determine total quantification of blood loss. Follow up & data recording; • Post-partum hemorrhage will be considered: 1. Minor PPH: if estimated blood loss from 500 ml to 1000 ml. 2. Major PPH: if any estimated blood loss is more than 1000 ml. Measuring hemoglobin level before & after 24 hours of delivery to asses the need for blood transfusion. All data will be recorded in Case Report Form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Intrapartum Hemorrhage
Keywords
estimated blood loss, carbetocin, oxytocin, misoprostol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Eligible patients will be randomised & allocated into 2 groups (A) & (B). Randomization will be done using computer generated list. Allocation & concealment will be done using sealed envelopes prepared according to computer generated list into ratio 1:1.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin+Misoprostol
Arm Type
Active Comparator
Arm Description
Patients in this group will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus.
Arm Title
Carbetocin
Arm Type
Experimental
Arm Description
Patients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.
Intervention Type
Drug
Intervention Name(s)
Oxytocin + misoprostol
Intervention Description
600 micrograms misoprostol rectally 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
100 micrograms carbetocin
Primary Outcome Measure Information:
Title
estimated blood loss in millimeters
Description
estimated blood lost during the cesarean section (CS)
Time Frame
calculated once at the end of the CS
Secondary Outcome Measure Information:
Title
drop in hemoglobin
Description
Difference in Hemoglobin level before and after CS
Time Frame
calculated once after 24hours of the CS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women planning to deliver by CS. Age between 18-40. Gestational age: (36-42 weeks). Exclusion Criteria: Women in active labour. Rupture of membranes more than 24 hours &/or intraamniotic infection. Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery. Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta. Major intrapartum hemorrhage more than 1000 ml. History of postpartum hemorrhage. Anemia (Hb level less than 10g/dl). Uterine overdistention eg: polyhydramnios, macrosomic baby, multiple pregnancy. Known allergy to any of misoprostol, oxytocin, carbetocin. Known medical disorders: Diabetes Mellitus, hypertensive disorders, Systemic Lupus Erythematosus. Known coagulopathy problem. Contraindication &/or refusal to spinal anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed SE Sweed, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol and the analytic code will be made available from the central contact on reasonable requests
IPD Sharing Time Frame
Data will be available after completion of the study and publishing the results, for 5 years therafter.
IPD Sharing Access Criteria
requests for data are to be sent at: raneyah@gmail.com

Learn more about this trial

Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section

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