NCT02165540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

May 19, 2014

Last Update Submit

January 6, 2016

Conditions

Uterine Evacuation

Keywords

DoulaPain managementMiscarriageAbortion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    At baseline visit and at 1-month follow-up

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

    At enrollment baseline and 1-month follow-up

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

    At enrollment baseline and 1-month follow up

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

    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

    At enrollment baseline

Study Arms (2)

Doula

EXPERIMENTAL

Patients will have a doula support person during their procedure.

Other: Doula

Routine care/No Doula

NO INTERVENTION

Patients will have routine care with clinical staff only.

Interventions

DoulaOTHER

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

Doula

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy is due to an incident of sexual assault or rape.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Family Planning and Pregnancy Loss Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

AgnosiaAbortion, Spontaneous

Interventions

Doulas

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Courtney Schreiber, MD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Obstetrics and Gynecology

Study Record Dates

First Submitted

May 19, 2014

First Posted

June 17, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(1)