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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doula Arm | Experimental | Women 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doula Arm | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 10 minutes post-procedure |
| Difficulty of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| 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. | 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). | At time of speculum insertion |
| Anticipated pain | To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS). | Prior to procedure |
| Pre-procedure anxiety | To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS). | 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). | Post-procedure |