Intravenous Nitroglycerin for Retained Placenta Extraction: a Multicenter Study
1 other identifier
interventional
100
1 country
1
Brief Summary
Primary objective The primary objective of this study is to see whether intravenous (IV) NTG 100-200 microgram can effectively help extract retained placenta as compared to placebo, in a randomized controlled multicenter study. Secondary objective is to compare the hypotensive effects of NTG as compared to placebo, including others side effects such as headache, blood loss, or others.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 28, 2008
CompletedFirst Posted
Study publicly available on registry
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 8, 2011
June 1, 2008
2.8 years
June 28, 2008
March 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
successful of placenta extraction
5 mintues
Secondary Outcomes (3)
hypotension
20 mintues
headache
2 hour
blood loss
24 hour
Study Arms (2)
1
ACTIVE COMPARATOR1=nitroglycerine 100 microgram intravenous100-200 microgram of IV.
2
PLACEBO COMPARATOR2=placebo with the same volume as NTG 100-200 microgram of IV.
Interventions
nitroglycerine 100 microgram intravenous.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
NSS.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
Eligibility Criteria
You may qualify if:
- Healthy pregnant patient (ASA classification I ,II )
- Normal pregnancy with at least 28 week gestation
You may not qualify if:
- ASA classification III and up
- Having complication of pregnancy such as hypertensive disease of pregnancy,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shusee Visalyaputra, MD
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 28, 2008
First Posted
July 1, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 8, 2011
Record last verified: 2008-06