Patient Support During Surgical Abortion

Surgical Abortion Clinical Trial

Official title:

Patient Support During Surgical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937988
• Other study ID #: 12-2246
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: July 29, 2014
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Abortion

Intervention

Other:
• Doula Arm

Locations

Country	Name	City	State
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Satisfaction with 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	No
Secondary	Difficulty of 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	No
Secondary	Duration of 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	No
Secondary	Pain 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	No
Secondary	Anticipated pain	To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).	Prior to procedure	No
Secondary	Pre-procedure anxiety	To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).	Prior to procedure	No
Secondary	Post-procedure recalled pain	To assess recalled pain 10 minutes post-procedure, as measured using a 100-mm Visual Analog Scale (VAS).	Post-procedure	No