The Periviable Birth Plan

NCT ID: NCT03061864

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Counseling

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Periviable Birth Plan

Intervention Type BEHAVIORAL

Interventions

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Periviable Birth Plan

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Paul Burcher Md, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Burcher, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

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Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Burcher, MD

Role: CONTACT

518-262-4942

Devon Jacobson, MD

Role: CONTACT

518-262-4942

Facility Contacts

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Paul Burcher, MD

Role: primary

518-262-4942

Devon Jacobson, MD

Role: backup

518-262-4942

Other Identifiers

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4622

Identifier Type: -

Identifier Source: org_study_id

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