The Periviable Birth Plan

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

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.

Study Overview

• Status: Unknown
• Conditions: PTSD; Anxiety; Pregnancy, High Risk; PreTerm Birth; Parturition Complication as Antepartum Condition
• Intervention / Treatment: Behavioral: Periviable Birth Plan

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Paul Burcher, MD; Phone Number: 518-262-4942
      • Contact: Devon Jacobson, MD; Phone Number: 518-262-4942; Email: jacobsd1@mail.amc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Counseling; Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology.
Experimental: Periviable Birth Plan; 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.	Behavioral: Periviable Birth Plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: Paul Burcher, MD, Albany Medical College

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2019
• Study Completion: August 1, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 19, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 19, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 4622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO