The Periviable Birth Plan

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061864
• Other study ID #: 4622
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2017
• Last updated: February 19, 2017
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: February 2017
• Source: Albany Medical College
• Contact: Paul Burcher, MD
• Phone: 518-262-4942
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Periviable Birth Plan

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time of Delivery and One Year
Primary	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.	Time of Delivery and One Year