The Periviable Birth Plan

Not Applicable

• Conditions: Anxiety; PreTerm Birth; PTSD; Pregnancy, High Risk; Parturition Complication as Antepartum Condition
• Interventions: Behavioral: Periviable Birth Plan

• Registration Number: NCT03061864
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2017-02
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-19
• Last Update Submitted: 2017-02-19
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periviable Birth Plan	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.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety Scores	Time of Delivery and One Year	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	Time of Delivery and One Year	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.

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States