The Impact of Doulas in Early Pregnancy Management

Study Overview
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Brief Summary
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The purpose of the study is to examine the impact of doula support for women undergoing a manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.

Detailed Description
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As a means of providing emotional support and physical comfort for all pregnant women, doulas have emerged in recent years in the world of clinical abortion care. Traditionally, doulas are non-medical individuals trained to provide emotional support, pain management strategies, relaxation techniques, and information to pregnant women during labor. The positive impact of doulas on obstetrical health outcomes and patient satisfaction is well accepted. Women with the support of a doula have been shown to have shorter labor, and rate birth as less difficult and more satisfying, than do mothers without doula support. They also report a greater ability to cope with labor and require less epidural and IV pain medication. In recent years, the term full spectrum doula has emerged to describe doulas who extend their supportive services to women at any stage of a pregnancy, including the management of a miscarriage or undesired pregnancy ending in abortion. The Doula Project, created in 2007 in New York City, and the Bay Area Doula Project, founded in 2011in San Francisco, were two of the first organized efforts to train doulas to provide abortion care and are now the largest in the United States. Scientific research on the impact of doulas during abortion and miscarriage management has been limited, but anecdotal reports from patients and providers suggest a positive impact on patient satisfaction. In this study we aim to test the impact of doulas on the physical, emotional, and overall experience among women undergoing a MVA for an early pregnancy failure or undesired pregnancy at the Penn Family Planning and Pregnancy Loss Center. We also aim to assess the impact of doula support from the medical assistants perception.

Official Title
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The Impact of Doulas in the Surgical Management of Early Pregnancy Failure and Abortion Care

Conditions
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Uterine Evacuation

Intervention / Treatment
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* Other: Doula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 years or older who is choosing to have a surgical procedure for the management of early pregnancy failure or undesired pregnancy. Pregnancy is not because of an incident of sexual assault or rape. Exclusion Criteria: Pregnancy is due to an incident of sexual assault or rape.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doula<br>Patients will have a doula support person during their procedure. | Other: Doula<br>* A specially trained support person or doula will accompany the patient to offer physical and emotional support during the procedure.<br>|
| No Intervention: Routine care/No Doula<br>Patients will have routine care with clinical staff only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of physical discomfort reported by women during their MVA procedure. | This data is obtained in-clinic via a brief questionnaire after the patient undergoes the MVA at enrollment baseline. | At enrollment baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree to which women report the ability to emotionally cope with their MVA procedure. | This data was obtained via a brief questionnaire before and after the MVA at enrollment baseline, and then via a brief survey completed over the phone 1 month after enrollment. | At baseline visit and at 1-month follow-up | 
| The degree to which women sense empowerment before and following their MVA procedure | This data was obtained via a brief questionnaire before and after the MVA at enrollment baseline, and then via a brief survey completed over the phone 1 month after enrollment. | At enrollment baseline and 1-month follow-up | 
| A rating of the emotional response experienced by women before and after their MVA procedure. | This data was obtained via a brief questionnaire before and after the MVA at enrollment baseline, and then via a brief survey completed over the phone 1 month after enrollment. | At enrollment baseline and 1-month follow up | 
| The degree to which women are satisfied by their MVA procedure experience | This data was obtained via a brief questionnaire after the MVA at enrollment baseline, and then via a brief survey completed over the phone 1 month after enrollment. | At enrollment baseline and 1-month follow-up | 
| The degree to which medical assistant reports a more positive or negative patient and personal experience with the MVA procedure | This data will be obtained via a Visual Analog Scale administered after the MVA procedure. | At enrollment baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Doula, Pain management, Miscarriage, Abortion