NCT01994317

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

November 1, 2013

Last Update Submit

August 14, 2015

Conditions

Pregnancy, Unplanned

Outcome Measures

Primary Outcomes (1)

  • Pain with suction curettage

    Subjects' pain score with suction curettage on a 0-100 21-point scale

    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

    Measured on Day 1 (day of enrollment), immediately after paracervical block

  • Pain with cervical dilation

    Measured on Day 1 (day of enrollment), immediately after cervical dilation

  • Post-operative pain

    Measured on Day 1 (day of enrollment), 15 minutes post-operatively

  • Patient satisfaction with pain control

    Measured on Day 1 (day of enrollment), 15 minutes post-operatively

  • Side effects

    Measured on Day 1 (day of enrollment), 15 minutes post-operatively

Other Outcomes (2)

  • Doses given over the duration of the study

    Measured on Day 1 (day of enrollment), intraoperatively

  • Physician assessment of pain control

    Measured on Day 1 (day of enrollment), post-operatively

Study Arms (2)

Standard sedation dose

ACTIVE COMPARATOR

IV sedation dose calculated using current standard of care

Other: Standard care

Algorithm

EXPERIMENTAL

IV sedation dose calculated by study algorithm

Other: Algorithm

Interventions

AlgorithmOTHER

IV sedation dosing calculated by algorithm

Algorithm
Standard careOTHER

IV sedation dosing calculated by standard care.

Standard sedation dose

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

AlgorithmsStandard of Care

Intervention Hierarchy (Ancestors)

Mathematical ConceptsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Principal Investigator, MD, MPH

    PPLM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

US(1)