Skip to main content
OpenTrials
Completed

NCT Number: NCT02165540

The Impact of Doulas in Early Pregnancy Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Evacuation Abortion, Spontaneous Agnosia Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn Family Planning and Pregnancy Loss Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doula

Other

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

Primary outcomes

  1. The degree of physical discomfort reported by women during their MVA procedure.

    Time frame: At enrollment baseline

    This data is obtained in-clinic via a brief questionnaire after the patient undergoes the MVA at enrollment baseline.

Secondary outcomes

  1. The degree to which women report the ability to emotionally cope with their MVA procedure.

    Time frame: At baseline visit and at 1-month follow-up

    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.

  2. The degree to which women sense empowerment before and following their MVA procedure

    Time frame: At enrollment baseline and 1-month follow-up

    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.

  3. A rating of the emotional response experienced by women before and after their MVA procedure.

    Time frame: At enrollment baseline and 1-month follow up

    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.

  4. The degree to which women are satisfied by their MVA procedure experience

    Time frame: At enrollment baseline and 1-month follow-up

    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.

  5. The degree to which medical assistant reports a more positive or negative patient and personal experience with the MVA procedure

    Time frame: At enrollment baseline

    This data will be obtained via a Visual Analog Scale administered after the MVA procedure.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2014
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.