Patient Support During Surgical Abortion

N/ACompletedNCT01937988

University of Chicago220 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Surgical Abortion

Interventions

Doula ArmOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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).

Time frame: At time of procedure

Secondary Outcomes

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)

Time frame: 10 minutes post-procedure

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.

Time frame: Immediately post-procedure

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.

Time frame: During procedure

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).

Time frame: At time of speculum insertion

Anticipated pain

To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).

Time frame: Prior to procedure

Pre-procedure anxiety

Data from ClinicalTrials.gov

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