Recruiting

Periviable Birth Plan

Sponsor:

Albany Medical College

Code:

NCT03061864

Conditions

Pregnancy, High Risk

Parturition Complication as Antepartum Condition

Anxiety

PTSD

PreTerm Birth

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Periviable Birth Plan

Study Details

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.

Conditions

Pregnancy, High Risk

Parturition Complication as Antepartum Condition

Anxiety

PTSD

PreTerm Birth

Study ID

NCT03061864

Start date

Aug, 2016

Status verified date

Feb, 2017

Completion date

Aug, 2019

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Periviable Birth Plan

Primary outcome measure

  • Change in Anxiety Scores [ Time Frame: Time of Delivery and One Year ]
  • Change in PTSD Scores [ Time Frame: Time of Delivery and One Year ]

Central Contacts and Locations

Central contacts

Paul Burcher, MD

518-262-4942

Devon Jacobson, MD

518-262-4942jacobsd1@mail.amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Paul Burcher, MD

518-262-4942

Devon Jacobson, MD

518-262-4942jacobsd1@mail.amc.edu

More Information

Sponsor

Albany Medical College

Last update posted

Feb 23, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2017-02-23.