Patient Support During Surgical Abortion
1 other identifier
interventional
220
1 country
1
Brief Summary
This study will be a non-blinded randomized controlled trial (RCT) of women presenting for abortion at \<13 6/7 weeks. Women will be randomized either to receive support by a trained abortion doula (intervention) or to have standard procedure (control) during the abortion procedure. The investigators hypothesize that women who receive doula support during a first trimester abortion will report less pain during the abortion procedure compared to women who do not receive abortion doula support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedJuly 30, 2014
July 1, 2014
2 months
September 4, 2013
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain at time of procedure
To determine the effect of abortion doula support during a 1st trimester abortion (\< 13 6/7 wks gestational age) on the pain at the time of the abortion, as measured using a 100-mm Visual Analog Scale (VAS).
At time of procedure
Secondary Outcomes (7)
Satisfaction with procedure
10 minutes post-procedure
Difficulty of procedure
Immediately post-procedure
Duration of procedure
During procedure
Pain at time of speculum insertion
At time of speculum insertion
Anticipated pain
Prior to procedure
- +2 more secondary outcomes
Study Arms (2)
Doula Arm
EXPERIMENTALWomen in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure.
Control Group
NO INTERVENTIONWomen in the control arm will have standard procedure protocol at the time of the procedure.
Interventions
Eligibility Criteria
You may qualify if:
- Aged \> 18 years
- Gestational age by sonogram \< 13 6/7 weeks gestation
- Desires pregnancy termination
- Ability to understand the study and give informed consent
- Ability to read and comprehend informed consent document in English
You may not qualify if:
- Aged \< 18 years
- Gestational age by sonogram \> 13 6/7 weeks gestation
- Inability to understand the study and give informed consent
- Inability to read and comprehend informed consent document in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2013
First Posted
September 10, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 30, 2014
Record last verified: 2014-07