Surgical AbortionNCT01937988
Patient Support During Surgical Abortion
A study testing Doula Arm in people with Surgical Abortion, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Abortion
- What is being tested?
- Doula Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612
About this study
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.
- Conditions
- Surgical Abortion
- Being tested
- Doula Arm
- Keywords
- Doula, Abortion, Pain, support
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula ArmOther
| Study group | Role | What they receive |
|---|---|---|
| Doula Arm | Experimental | Women in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure. Receives: Other: Doula Arm |
| Control Group | No intervention | Women in the control arm will have standard procedure protocol at the time of the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At time of procedure
Secondary outcomes (7)
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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At time of speculum insertion
Anticipated pain
To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Measured: Prior to procedure
Pre-procedure anxiety
To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Measured: Prior to procedure
Post-procedure recalled pain
To assess recalled pain 10 minutes post-procedure, as measured using a 100-mm Visual Analog Scale (VAS).
Measured: Post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical AbortionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937988
- Sponsor's protocol ID
- 12-2246
- Status last verified
- Jul 2014
- First submitted
- 4 Sep 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Support During Surgical Abortion
- ClinicalTrials.gov ID
- NCT01937988
- Acronym / sponsor ID
- 12-2246
- Conditions
- Surgical Abortion
- Keywords
- Doula, Abortion, Pain, support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula Arm | Experimental | Other: Doula ArmWomen in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure. |
| Control Group | No intervention | –Women in the control arm will have standard procedure protocol at the time of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula Arm | Other | Doula Arm |
Primary outcome
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).
7 secondary outcomes
Satisfaction with procedure
Time frame: 10 minutes post-procedure
Difficulty of procedure
Time frame: Immediately post-procedure
Duration of procedure
Time frame: During procedure
Pain at time of speculum insertion
Time frame: At time of speculum insertion
Anticipated pain
Time frame: Prior to procedure
Pre-procedure anxiety
Time frame: Prior to procedure
Post-procedure recalled pain
Time frame: Post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula Arm in people with Surgical Abortion, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at time of procedure (time frame: At time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.