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Misoprostol+Oxytocin vs. Carbetocin in CS (CS)

Primary Purpose

Cesarean Section

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Carbetocin
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring Misoprostol, Oxytocin, Carbetocin, Prevention, Post-partum hemorrhage

Eligibility Criteria

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

Inclusion Criteria:

  • Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

Exclusion Criteria:

  • hypersensitivity to oxytocin, carbetocin or prostaglandins
  • contraindication to prostaglandins (e.g. glaucoma)
  • history of significant heart disease
  • severe asthma
  • epilepsy
  • history or evidence of liver
  • renal or vascular disease
  • history of coagulopathy
  • thrombocytopenia or anticoagulant therapy
  • women with HELLP syndrome
  • eclampsia
  • women presenting by placental abruption
  • contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Misoprostol + Oxytocin

Carbetocin

Arm Description

400 ug sublingual misoprostol + 10 IU Oxytocin IVI

100 ug Carbetocin IV

Outcomes

Primary Outcome Measures

incidence of post-partum hemorrhage
amount of blood loss

Secondary Outcome Measures

Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)
An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.
Number of participants needing hemostatic surgical interventions
Hemoglobin deficit in gm/dl
difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
APGAR score at 1 minute and 5 minutes
Number of participants with NICU admission
Drug side effects
Time till resuming bowel habits
Time of passing gas will be recorded how many hours post-operative
hematocrit deficit in %
difference between pre-operative and 24 hours post-operative hematocrit in %

Full Information

First Posted
May 24, 2016
Last Updated
July 7, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02786992
Brief Title
Misoprostol+Oxytocin vs. Carbetocin in CS
Acronym
CS
Official Title
Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
Misoprostol, Oxytocin, Carbetocin, Prevention, Post-partum hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol + Oxytocin
Arm Type
Active Comparator
Arm Description
400 ug sublingual misoprostol + 10 IU Oxytocin IVI
Arm Title
Carbetocin
Arm Type
Active Comparator
Arm Description
100 ug Carbetocin IV
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Mesotec, Mesotac
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Pabal
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
incidence of post-partum hemorrhage
Time Frame
24 hours
Title
amount of blood loss
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)
Description
An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.
Time Frame
24 hours
Title
Number of participants needing hemostatic surgical interventions
Time Frame
intra-operative
Title
Hemoglobin deficit in gm/dl
Description
difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
Time Frame
24 hours
Title
APGAR score at 1 minute and 5 minutes
Time Frame
1 minute and 5 minutes
Title
Number of participants with NICU admission
Time Frame
24 hours
Title
Drug side effects
Time Frame
24 hours
Title
Time till resuming bowel habits
Description
Time of passing gas will be recorded how many hours post-operative
Time Frame
24 hours
Title
hematocrit deficit in %
Description
difference between pre-operative and 24 hours post-operative hematocrit in %
Time Frame
24 hours

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: Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks). Exclusion Criteria: hypersensitivity to oxytocin, carbetocin or prostaglandins contraindication to prostaglandins (e.g. glaucoma) history of significant heart disease severe asthma epilepsy history or evidence of liver renal or vascular disease history of coagulopathy thrombocytopenia or anticoagulant therapy women with HELLP syndrome eclampsia women presenting by placental abruption contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Misoprostol+Oxytocin vs. Carbetocin in CS

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