Pregnancy, UnplannedNCT01994317
Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
A study testing Algorithm in people with Pregnancy, Unplanned, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial summary
This study aims to compare an algorithm for IV sedation dosing to the current standard of care in patients undergoing first trimester surgical abortion. The primary outcome is subjects' pain score with suction curettage on a 0-100 21-point scale. 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
- Pregnancy, Unplanned
- What is being tested?
- Algorithm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2015
- 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
- Women age 18 or older seeking surgical abortion at Planned Parenthood League of Massachusetts (PPLM)
- Gestational age less than or equal to 13+6, confirmed by ultrasound
- Eligible for surgical abortion according to PPLM protocols
- Eligible for IV sedation per PPLM protocol, and desiring IV sedation for pain management
Who cannot join
- Choice of local anesthesia for pain control
- Hypersensitivity to midazolam or fentanyl
- Ineligible for IV sedation per PPLM protocol
- Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
- Unable or unwilling to complete required study procedures
- Previous participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare an algorithm for IV sedation dosing to the current standard of care in patients undergoing first trimester surgical abortion. The primary outcome is subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain ratings, incidents of side effects and adverse events, the frequency of additional doses of medication, recovery room time, and physician assessment of and satisfaction with pain control. Investigators hypothesize that this algorithm will result in improved pain control, decreased frequency of additional medication doses, improved patient and physician satisfaction, without differences in side effects, adverse events or recovery room time.
- Conditions
- Pregnancy, Unplanned
- Being tested
- Algorithm, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgorithmOther
IV sedation dosing calculated by algorithm
Standard careOther
IV sedation dosing calculated by standard care.
| Study group | Role | What they receive |
|---|---|---|
| Standard sedation dose | Active comparator | IV sedation dose calculated using current standard of care Receives: Other: Standard care |
| Algorithm | Experimental | IV sedation dose calculated by study algorithm Receives: Other: Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with suction curettage
Subjects' pain score with suction curettage on a 0-100 21-point scale
Measured: Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal
Secondary outcomes (5)
Pain with paracervical block
Pain with paracervical block will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain." Pain will be measured immediately after paracervical block.
Measured: Measured on Day 1 (day of enrollment), immediately after paracervical block
Pain with cervical dilation
Pain with cervical dilation will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain." Pain with cervical dilation will be measured immediately after cervical dilation.
Measured: Measured on Day 1 (day of enrollment), immediately after cervical dilation
Post-operative pain
Post-operative pain will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain." Pain will be measured 15 minutes post-operatively when the patient is in the recovery room.
Measured: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Patient satisfaction with pain control
Patients will be asked about their general satisfaction with pain control, what their pain was compared to what they expected, whether they would chose the same pain management strategy again, and whether they would recommend their strategy of pain management to a friend.
Measured: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Side effects
Investigators will assess side effects for all patients, including nausea, vomiting, dizziness, and drowsiness.
Measured: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, UnplannedStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, MPH, Principal investigator, PPLM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994317
- Sponsor's protocol ID
- SFPRF7-6
- Status last verified
- Aug 2015
- First submitted
- 1 Nov 2013
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT01994317
- Acronym / sponsor ID
- SFPRF7-6
- Conditions
- Pregnancy, Unplanned
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Nov 2013 (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.
This study aims to compare an algorithm for IV sedation dosing to the current standard of care in patients undergoing first trimester surgical abortion. The primary outcome is subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain ratings, incidents of side effects and adverse events, the frequency of additional doses of medication, recovery room time, and physician assessment of and satisfaction with pain control. Investigators hypothesize that this algorithm will result in improved pain control, decreased frequency of additional medication doses, improved patient and physician satisfaction, without differences in side effects, adverse events or recovery room time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard sedation dose | Active comparator | Other: Standard careIV sedation dose calculated using current standard of care |
| Algorithm | Experimental | Other: AlgorithmIV sedation dose calculated by study algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women age 18 or older seeking surgical abortion at Planned Parenthood League of Massachusetts (PPLM)
- Gestational age less than or equal to 13+6, confirmed by ultrasound
- Eligible for surgical abortion according to PPLM protocols
- Eligible for IV sedation per PPLM protocol, and desiring IV sedation for pain management
Key exclusion criteria (6 listed)
- Choice of local anesthesia for pain control
- Hypersensitivity to midazolam or fentanyl
- Ineligible for IV sedation per PPLM protocol
- Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
- Unable or unwilling to complete required study procedures
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 |
|---|---|---|
| AlgorithmIV sedation dosing calculated by algorithm | Other | Algorithm |
| Standard careIV sedation dosing calculated by standard care. | Other | Standard sedation dose |
Primary outcome
Pain with suction curettage
Time frame: Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal
Subjects' pain score with suction curettage on a 0-100 21-point scale
5 secondary outcomes
Pain with paracervical block
Time frame: Measured on Day 1 (day of enrollment), immediately after paracervical block
Pain with cervical dilation
Time frame: Measured on Day 1 (day of enrollment), immediately after cervical dilation
Post-operative pain
Time frame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Patient satisfaction with pain control
Time frame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Side effects
Time frame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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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.
Principal Investigator, MD, MPH principal investigator
PPLM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm in people with Pregnancy, Unplanned, 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 6 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: finished, as of the sponsor's last update on 17 Aug 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 with suction curettage (time frame: Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2015; AzTrials last refreshed its copy on 31 Oct 2026.