Study Stopped
DSMB review at 50% recruitment, further recruitment unlikely to change result
Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)
A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
1 other identifier
interventional
132
1 country
1
Brief Summary
The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2006
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
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 15, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMarch 18, 2016
March 1, 2016
1.1 years
June 15, 2006
March 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pain scale
Secondary Outcomes (1)
Measures of satisfaction, side effects, recovery time
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 or older.
- Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
- Has already signed consent for pregnancy termination.
- Eligible for IV sedation per clinic protocol.
You may not qualify if:
- Under 120 lbs.
- Allergies to any of the drugs being studied.
- Chronic narcotics, barbiturates or benzodiazepine use within the past year.
- History of IV drug use within the last year.
- Inability to give informed consent.
- Does not speak English or Spanish and does not have translator for all study procedures
- Previously participated in study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215, United States
Related Publications (1)
Allen RH, Fitzmaurice G, Lifford KL, Lasic M, Goldberg AB. Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):276-83. doi: 10.1097/AOG.0b013e3181938758.
PMID: 19155895DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Doe
Planned Parenthood League of Massachusetts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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 15, 2006
First Posted
June 16, 2006
Study Start
June 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
March 18, 2016
Record last verified: 2016-03