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The Periviable Birth Plan

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03061864
Enrollment
54
Registered
2017-02-23
Start date
2016-08-31
Completion date
2019-08-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALPeriviable Birth Plan

Sponsors

Albany Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Anxiety ScoresTime of Delivery and One YearPatients 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 ScoresTime of Delivery and One YearPatients 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.

Countries

United States

Contacts

Primary ContactPaul Burcher, MD
518-262-4942
Backup ContactDevon Jacobson, MD
jacobsd1@mail.amc.edu518-262-4942

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026