Patient Support During Surgical Abortion

The University of Chicago

Status: Completed

Conditions: Surgical Abortion

Treatments: Other: Doula Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01937988

12-2246

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Doula Arm

Experimental group

Description:

Women in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure.

Treatment:

Other: Doula Arm

Control Group

No Intervention group

Description:

Women in the control arm will have standard procedure protocol at the time of the procedure.