The Impact of Doulas in Early Pregnancy Management

NCT ID: NCT02165540

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-02-28

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.

Conditions

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Uterine Evacuation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Doula

Patients will have a doula support person during their procedure.

Group Type EXPERIMENTAL

Doula

Intervention Type OTHER

A specially trained support person or doula will accompany the patient to offer physical and emotional support during the procedure.

Routine care/No Doula

Patients will have routine care with clinical staff only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Doula

A specially trained support person or doula will accompany the patient to offer physical and emotional support during the procedure.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Courtney Schreiber

Assistant Professor, Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Courtney Schreiber, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Penn Family Planning and Pregnancy Loss Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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819173

Identifier Type: -

Identifier Source: org_study_id

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