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Patient Support During Surgical Abortion

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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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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