Uterine EvacuationNCT02165540
The Impact of Doulas in Early Pregnancy Management
A study testing Doula in people with Uterine Evacuation, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Evacuation
- What is being tested?
- Doula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy is due to an incident of sexual assault or rape.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Family Planning and Pregnancy Loss Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Impact of Doulas in the Surgical Management of Early Pregnancy Failure and Abortion Care
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.
Read the 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.
- Conditions
- Uterine Evacuation
- Being tested
- Doula
- Keywords
- Doula, Pain management, Miscarriage, Abortion
- Medical subject headings
- Agnosia, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoulaOther
A specially trained support person or doula will accompany the patient to offer physical and emotional support during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Doula | Experimental | Patients will have a doula support person during their procedure. Receives: Other: Doula |
| Routine care/No Doula | No intervention | Patients will have routine care with clinical staff only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine EvacuationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Schreiber, University of Pennsylvania
- Investigators
- Courtney Schreiber, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165540
- Sponsor's protocol ID
- 819173
- Status last verified
- Jan 2016
- First submitted
- 19 May 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Doulas in the Surgical Management of Early Pregnancy Failure and Abortion Care
- ClinicalTrials.gov ID
- NCT02165540
- Acronym / sponsor ID
- 819173
- Conditions
- Uterine Evacuation
- Keywords
- Doula, Pain management, Miscarriage, Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula | Experimental | Other: DoulaPatients will have a doula support person during their procedure. |
| Routine care/No Doula | No intervention | –Patients will have routine care with clinical staff only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy is due to an incident of sexual assault or rape.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoulaA specially trained support person or doula will accompany the patient to offer physical and emotional support during the procedure. | Other | Doula |
Primary outcome
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.
5 secondary outcomes
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
The degree to which women sense empowerment before and following their MVA procedure
Time frame: At enrollment baseline and 1-month follow-up
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
The degree to which women are satisfied by their MVA procedure experience
Time frame: 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
Time frame: At enrollment baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
Related trials for Uterine Evacuation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Schreiber, MD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula in people with Uterine Evacuation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of physical discomfort reported by women during their MVA procedure. (time frame: At enrollment baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.