Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
Primary Purpose
Labor Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oxytocin
misoprostol
Sponsored by
About this trial
This is an interventional prevention trial for Labor Complication
Eligibility Criteria
Inclusion Criteria:
- vaginal birth in women who had blood loss >300 ml
Exclusion Criteria:
- <37 weeks of pregnancy,
- genital tract injuries,
- coagulation deficit,
- hypertension, preeclampsia,
- cardiac, renal, or hepatic disease,
- epilepsy,
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
oxytocin
misoprostol
Arm Description
20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
Outcomes
Primary Outcome Measures
measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
measured amount of blood loss ≥ 300 mills after PPH treatment
Secondary Outcome Measures
change in hemoglobin
measure change of hemoglobin
need for additional interventions
number of patients need additional interventions ,like uterine aetry ligation
Full Information
NCT ID
NCT05077540
First Posted
October 1, 2021
Last Updated
October 14, 2021
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05077540
Brief Title
Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
Official Title
The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University 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
Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss >300 ml .
Detailed Description
The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO).
Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blinded a randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blinded a randomized controlled trial
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oxytocin
Arm Type
Active Comparator
Arm Description
20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
Arm Title
misoprostol
Arm Type
Experimental
Arm Description
800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
Active Comparator
Intervention Description
20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
Intervention Type
Drug
Intervention Name(s)
misoprostol
Other Intervention Name(s)
Active Comparator
Intervention Description
800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
Primary Outcome Measure Information:
Title
measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
Description
measured amount of blood loss ≥ 300 mills after PPH treatment
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
change in hemoglobin
Description
measure change of hemoglobin
Time Frame
12 hours
Title
need for additional interventions
Description
number of patients need additional interventions ,like uterine aetry ligation
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
vaginal birth in women who had blood loss >300 ml
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
vaginal birth in women who had blood loss >300 ml
Exclusion Criteria:
<37 weeks of pregnancy,
genital tract injuries,
coagulation deficit,
hypertension, preeclampsia,
cardiac, renal, or hepatic disease,
epilepsy,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
Phone
+201112501460
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w waer, md
Phone
+201022336052
Ext
002
Email
nahlagyn@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
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