Patient Support During Surgical Abortion

July 29, 2014 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doula Arm
Women in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure.
Other: Doula Arm
No Intervention: Control Group
Women in the control arm will have standard procedure protocol at the time of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at time of procedure
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with procedure
Time Frame: 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)
10 minutes post-procedure
Difficulty of procedure
Time Frame: 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.
Immediately post-procedure
Duration of procedure
Time Frame: 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.
During procedure
Pain at time of speculum insertion
Time Frame: 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).
At time of speculum insertion
Anticipated pain
Time Frame: Prior to procedure
To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Prior to procedure
Pre-procedure anxiety
Time Frame: Prior to procedure
To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Prior to procedure
Post-procedure recalled pain
Time Frame: Post-procedure
To assess recalled pain 10 minutes post-procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-2246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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