Pregnancy, High RiskNCT03061864
The Periviable Birth Plan
A study testing Periviable Birth Plan in people with Pregnancy, High Risk and Parturition Complication as Antepartum Condition, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, High Risk, Parturition Complication as Antepartum Condition, Anxiety
- What is being tested?
- Periviable Birth Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old.
- Currently Pregnant
- High risk of pre-term birth in the periviable period 20+0 to 25+6 wga
Who cannot join
- Intrauterine Fetal Demise (prior to admission)
- Inability to read or communicate in english
Trial locations and contacts
1 site in 1 country.
Paul Burcher, MD contact
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Paul Burcher, MD, 518-262-4942
Devon Jacobson, MD, 518-262-4942, jacobsd1@mail.amc.edu
About this study
Official title: 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.
- Conditions
- Pregnancy, High Risk, Parturition Complication as Antepartum Condition, Anxiety, PTSD, PreTerm Birth
- Being tested
- Periviable Birth Plan
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periviable Birth PlanBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard Counseling | No intervention | Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology. |
| Periviable Birth Plan | Experimental | 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. Receives: Behavioral: Periviable Birth Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time of Delivery and One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Burcher Md, PhD, Albany Medical College
- Investigators
- Paul Burcher, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061864
- Sponsor's protocol ID
- 4622
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Periviable Birth Plan: A Randomized Control Trial Evaluating an Intervention to Decrease Maternal Anxiety and Stress
- ClinicalTrials.gov ID
- NCT03061864
- Acronym / sponsor ID
- 4622
- Conditions
- Pregnancy, High Risk, Parturition Complication as Antepartum Condition, Anxiety, PTSD, PreTerm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Counseling | No intervention | –Patients at risk of delivery between 20 and 25+6 weeks gestation will receive the normal counseling from Ob/gyn and Neonatology. |
| Periviable Birth Plan | Experimental | Behavioral: Periviable Birth PlanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old.
- Currently Pregnant
- High risk of pre-term birth in the periviable period 20+0 to 25+6 wga
Key exclusion criteria (2 listed)
- Intrauterine Fetal Demise (prior to admission)
- Inability to read or communicate in english
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periviable Birth Plan | Behavioural | Periviable Birth Plan |
Primary outcome
Change in Anxiety Scores
Time frame: 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 frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Burcher, MD contact
Paul Burcher, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periviable Birth Plan in people with Pregnancy, High Risk and Parturition Complication as Antepartum Condition, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Burcher, MD (518-262-4942), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Scores (time frame: Time of Delivery and One Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.