Patient Support During Surgical Abortion

Not Applicable

Completed

• Conditions: Surgical Abortion
• Interventions: Other: Doula Arm

• Registration Number: NCT01937988
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doula Arm	Doula Arm	Women in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure.

Primary Outcome Measures

Name	Time	Method
Pain at time of procedure	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).

Secondary Outcome Measures

Name	Time	Method
Satisfaction with procedure	10 minutes post-procedure	To assess the impact of abortion doula support on a woman's overall satisfaction with the abortion experience, as measured using a 100-mm Visual Analog Scale (VAS)
Pain at time of speculum insertion	At time of speculum insertion	To determine the effect of abortion doula support during a 1st trimester abortion on the pain at the time of speculum insertion, as measured using a 100-mm Visual Analog Scale (VAS).
Anticipated pain	Prior to procedure	To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Pre-procedure anxiety	Prior to procedure	To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Difficulty of procedure	Immediately post-procedure	To assess the impact of abortion doula support on the provider's assessment of difficulty of procedure, as measured using a 4-point Likert scale.
Duration of procedure	During procedure	To assess the impact of doula support on the duration of the procedure, from placement of the speculum to removal of the speculum upon completion of the procedure.
Post-procedure recalled pain	Post-procedure	To assess recalled pain 10 minutes post-procedure, as measured using a 100-mm Visual Analog Scale (VAS).

Trial Locations

Locations (1)

John H. Stroger, Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States