Surgical Abortion
Conditions
Keywords
Doula, Abortion, Pain, support
Brief 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. 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.
Interventions
OTHERDoula Arm
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at time of procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Difficulty of procedure | 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. |
| Duration of procedure | 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. |
| Pain at time of speculum insertion | 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). |
| Satisfaction with procedure | 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) |
| Pre-procedure anxiety | Prior to procedure | To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS). |
| Post-procedure recalled pain | Post-procedure | To assess recalled pain 10 minutes post-procedure, as measured using a 100-mm Visual Analog Scale (VAS). |
| Anticipated pain | Prior to procedure | To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS). |
Countries
United States
Outcome results
None listed