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OpenTrials
Completed

NCT Number: NCT01937988

Patient Support During Surgical Abortion

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.

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Key information

Conditions

Surgical Abortion Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doula Arm

Other

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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).

  5. Anticipated pain

    Time frame: Prior to procedure

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

  6. Pre-procedure anxiety

    Time frame: Prior to procedure

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

  7. 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).

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2013
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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