Clinical trial NCT02165540: The Impact of Doulas in Early Pregnancy Management
Official title: The Impact of Doulas in the Surgical Management of Early Pregnancy Failure and Abortion Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Evacuation
Keywords: Doula
Pain management
Miscarriage
Abortion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The degree of physical discomfort reported by women during their MVA procedure.
timeFrame: At enrollment baseline
Secondary outcomes:
measure: The degree to which women report the ability to emotionally cope with their MVA procedure.
timeFrame: At baseline visit and at 1-month follow-up
measure: The degree to which women sense empowerment before and following their MVA procedure
timeFrame: At enrollment baseline and 1-month follow-up
measure: A rating of the emotional response experienced by women before and after their MVA procedure.
timeFrame: At enrollment baseline and 1-month follow up
measure: The degree to which women are satisfied by their MVA procedure experience
timeFrame: At enrollment baseline and 1-month follow-up
measure: The degree to which medical assistant reports a more positive or negative patient and personal experience with the MVA procedure
timeFrame: At enrollment baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Family Planning and Pregnancy Loss Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Courtney Schreiber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: