Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: a Randomized Controlled Trial
1 other identifier
interventional
150
0 countries
N/A
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 22, 2021
October 1, 2021
2 years
October 1, 2021
October 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
measured amount of blood loss ≥ 300 mills after PPH treatment
24 hours
Secondary Outcomes (2)
change in hemoglobin
12 hours
need for additional interventions
24 hours
Study Arms (2)
oxytocin
ACTIVE COMPARATOR20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
misoprostol
EXPERIMENTAL800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
Interventions
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)
Eligibility Criteria
You may qualify if:
- vaginal birth in women who had blood loss \>300 ml
You may not qualify if:
- \<37 weeks of pregnancy,
- genital tract injuries,
- coagulation deficit,
- hypertension, preeclampsia,
- cardiac, renal, or hepatic disease,
- epilepsy,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double-blinded a randomized controlled trial
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 1, 2021
First Posted
October 14, 2021
Study Start
November 1, 2021
Primary Completion
October 31, 2023
Study Completion
December 31, 2023
Last Updated
October 22, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share