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The Periviable Birth Plan

Primary Purpose

Pregnancy, High Risk, Parturition Complication as Antepartum Condition, Anxiety

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Periviable Birth Plan

About this trial

This is an interventional treatment trial for Pregnancy, High Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18 years old.
Currently Pregnant
High risk of pre-term birth in the periviable period 20+0 to 25+6 wga

Exclusion Criteria:

Intrauterine Fetal Demise (prior to admission)
Inability to read or communicate in english

Sites / Locations

Albany Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Counseling

Periviable Birth Plan

Arm Description

Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology.

Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology with completion of the written periviable birth plan.

Outcomes

Primary Outcome Measures

Change in Anxiety Scores

Patients will complete State Trait Anxiety Inventory questionnaire at the time of delivery and again at 1 year from completion of the first questionnaire. Those that do not deliver in the periviable period will complete the first questionnaire at 27 weeks gestation.

Change in PTSD Scores

Patients will complete Impact of Events Scale questionnaire at the time of delivery and again at 1 year from completion of the first questionnaire. Those that do not deliver in the periviable period will complete the first questionnaire at 27 weeks gestation.

Secondary Outcome Measures

Full Information

NCT ID

NCT03061864

First Posted

February 14, 2017

Last Updated

February 19, 2017

Sponsor

Albany Medical College

1. Study Identification

Unique Protocol Identification Number

NCT03061864

Brief Title

The Periviable Birth Plan

Official Title

The Periviable Birth Plan: A Randomized Control Trial Evaluating an Intervention to Decrease Maternal Anxiety and Stress

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

August 2019 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albany Medical College

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over their own pregnancy. There is some evidence that more counseling and planning can help reduce maternal stress and anxiety. Patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, High Risk, Parturition Complication as Antepartum Condition, Anxiety, PTSD, PreTerm Birth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Counseling

Arm Type

No Intervention

Arm Description

Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology.

Arm Title

Periviable Birth Plan

Arm Type

Experimental

Arm Description

Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology with completion of the written periviable birth plan.

Intervention Type

Behavioral

Intervention Name(s)

Periviable Birth Plan

Primary Outcome Measure Information:

Title

Change in Anxiety Scores

Description

Time Frame

Time of Delivery and One Year

Title

Change in PTSD Scores

Description

Time Frame

Time of Delivery and One Year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old. Currently Pregnant High risk of pre-term birth in the periviable period 20+0 to 25+6 wga Exclusion Criteria: Intrauterine Fetal Demise (prior to admission) Inability to read or communicate in english

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Burcher, MD

Phone

518-262-4942

First Name & Middle Initial & Last Name or Official Title & Degree

Devon Jacobson, MD

Phone

518-262-4942

jacobsd1@mail.amc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Burcher, MD

Organizational Affiliation

Albany Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Burcher, MD

Phone

518-262-4942

First Name & Middle Initial & Last Name & Degree

Devon Jacobson, MD

Phone

518-262-4942

jacobsd1@mail.amc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Periviable Birth Plan

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