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Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Health Services Research
Participants needed
75 (estimated)
Sponsor
University of Montana · Other
Who this trial is looking for
This trial is looking for pregnant women living in rural Montana to participate in a study about doula support during pregnancy and after childbirth. Participants will receive either traditional doula care, specialized doula care, or standard pregnancy care.
Are You a Good Fit for This Trial?
You may be able to join if
I am over the age of 18
I am currently pregnant
I am between 13 and 26 weeks along in my pregnancy
I live in a HRSA-designated rural area of Montana
You may not be able to join if
I am under the age of 18
I am not currently pregnant
I am not between 13-26 weeks along in my pregnancy
I do not live in a HRSA-designated rural area of Montana
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a …
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants must be over the age of 18
* Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment
* Live in a HRSA-designated rural area of Montana
Exclusion Criteria:
* They are under the age of 18
* Not currently pregnant
* Not between 13-26 ge…
Inclusion Criteria:
* Participants must be over the age of 18
* Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment
* Live in a HRSA-designated rural area of Montana
Exclusion Criteria:
* They are under the age of 18
* Not currently pregnant
* Not between 13-26 gestational weeks at the time of enrollment
* If they do not live in a HRSA-designated rural are of Montana.
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