Undesired PregnancyNCT00337792
Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)
A study testing oxycodone + lorazepam versus fentanyl + midazolam in people with Undesired Pregnancy, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Undesired Pregnancy
- What is being tested?
- oxycodone + lorazepam versus fentanyl + midazolam
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
About this study
Official title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
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.
Read the detailed description
The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary 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.
- Conditions
- Undesired Pregnancy
- Being tested
- oxycodone + lorazepam versus fentanyl + midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodone + lorazepam versus fentanyl + midazolamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
Secondary outcomes (1)
Measures of satisfaction, side effects, recovery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: DSMB review at 50% recruitment, further recruitment unlikely to change result
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Undesired PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Investigators
- Jane Doe, Principal investigator, Planned Parenthood League of Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337792
- Sponsor's protocol ID
- 2005-P-002284/1
- Status last verified
- Mar 2016
- First submitted
- 15 Jun 2006
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19155895
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT00337792
- Acronym / sponsor ID
- 2005-P-002284/1
- Conditions
- Undesired Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB review at 50% recruitment, further recruitment unlikely to change result
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxycodone + lorazepam versus fentanyl + midazolam | Drug | – |
Primary outcome
Pain scale
1 secondary outcome
Measures of satisfaction, side effects, recovery time
Results and safety
The study was stopped early (reason given: DSMB review at 50% recruitment, further recruitment unlikely to change result). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Derived from this study: PubMed 19155895Allen 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.
Related trials for Undesired Pregnancy
Active, not recruitingObservational study
Attitudes and Decision-making After Pregnancy Testing Study
Unintended Pregnancy, Undesired Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Doe principal investigator
Planned Parenthood League of Massachusetts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxycodone + lorazepam versus fentanyl + midazolam in people with Undesired Pregnancy, run by Planned Parenthood League of Massachusetts at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DSMB review at 50% recruitment, further recruitment unlikely to change result). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.