CLINICAL TRIAL

Writing exercises for Adverse Birth Outcomes

Recruiting · 18 - 65 · Female · Chapel Hill, NC

Therapeutic Writing to Reduce Stress

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About the trial for Adverse Birth Outcomes

Eligible Conditions
Stress, Physiological · High Risk Pregnancies · Pregnancy Complications

Treatment Groups

This trial involves 2 different treatments. Writing Exercises is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Writing exercises
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Writing exercises
OTHER

Eligibility

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Singleton viable intrauterine pregnancy, with dating confirmed by ultrasound or plans for ultrasound to confirm dating prior to study enrollment
ii. The previous preterm delivery cannot be an antepartum stillbirth but an intrapartum stillbirth (due to extreme prematurity) is allowable.
c. Chronic hypertension on medications d. History of pre-eclampsia requiring delivery <37 weeks' gestation, or history of severe pre-eclampsia delivering at any gestational age
Women will be prospectively recruited.
Gestational age: All women presenting for prenatal care at 8.0 to 19.9 weeks' gestation through the UNC-Hospitals High Risk obstetrics clinic will be screened for high risk of an adverse pregnancy outcome (ex: preterm birth or pre-eclampsia) through review of their medical record.
No structural abnormalities or aneuploidy
OR Prior preterm birth 34.0-36.9 weeks
Chronic hypertension not requiring medications
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: through study completion, an average of 7 months per participant and 2 years for entire study
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: through study completion, an average of 7 months per participant and 2 years for entire study.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Writing exercises will improve 7 primary outcomes and 7 secondary outcomes in patients with Adverse Birth Outcomes. Measurement will happen over the course of outcome will be ascertained at delivery.

Proportion of women with adverse perinatal outcomes
OUTCOME WILL BE ASCERTAINED AT DELIVERY
We will define adverse pregnancy outcomes as a composite of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Stress related pathways gene expression - placental tissue - by diagnosis of adverse perinatal outcome
THROUGH STUDY COMPLETION, AN AVERAGE OF 7 MONTHS PER PARTICIPANT AND 2 YEARS FOR ENTIRE STUDY
After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by whether or not the patient developed the adverse perinatal outcome
Rate of diagnosis of preeclampsia by randomization group
THROUGH STUDY COMPLETION, AN AVERAGE OF 7 MONTHS PER PARTICIPANT AND 2 YEARS FOR ENTIRE STUDY
we will individually evaluate the outcomes of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Rate of preterm birth less than 37 weeks' gestation by randomization group
THROUGH STUDY COMPLETION, AN AVERAGE OF 7 MONTHS PER PARTICIPANT AND 2 YEARS FOR ENTIRE STUDY
we will individually evaluate the outcomes of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Change in stress-related gene expression in maternal blood by randomization group
THROUGH STUDY COMPLETION, AN AVERAGE OF 7 MONTHS PER PARTICIPANT AND 2 YEARS FOR ENTIRE STUDY
All women participating in the study will have a blood draw. We will evaluate gene expression of the CTRA gene panel (conserved transcriptional response to adversity gene panel) by randomization group
Change in pro-inflammatory biomarkers in maternal blood by outcome
THROUGH STUDY COMPLETION, AN AVERAGE OF 7 MONTHS PER PARTICIPANT AND 2 YEARS FOR ENTIRE STUDY
All women participating in the study will have a blood draw. Levels of stress biomarkers (e.g., interleukin-6) will be compared between women who develop the adverse perinatal outcome and those who do not
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the latest developments in writing exercises for therapeutic use?

Currently, writing exercises are used mainly in psychotherapy, yet they have also been proposed as a new clinical method for enhancing therapeutic outcomes in other psychotherapies, such as cognitive behavior therapy and relational psychoanalysis.

Anonymous Patient Answer

How many people get adverse birth outcomes a year in the United States?

There is one infant mortality per 400 deliveries. There are 7 adverse birth outcomes for every 100,000 live births. There is one neonatal mortality per 18,200 live births. There are 9 adverse birth outcomes per 1000 pregnancies.

Anonymous Patient Answer

What causes adverse birth outcomes?

Complicated births were more likely to cause an adverse birth outcome. This highlights the importance of considering the interaction of obstetric and perinatal factors in relation the causal pathways from conception through to the start of the newborn period.

Anonymous Patient Answer

What are common treatments for adverse birth outcomes?

Medications are commonly used by pregnant women to treat a variety of disorders and for medications from the category of medications of conception, which are commonly used are NSAIDs and/or nonsteroidal antiinflammatory drugs.

Anonymous Patient Answer

What are the signs of adverse birth outcomes?

The following are a sample of adverse birth outcomes and their signs: stillbirth, preterm birth, intrauterine growth retardation (>10% ), low birth weight (<2500 g), birth trauma, breech birth and high-risk pregnancies. (2) A systematic review of the literature and case reports are also reported. (3) A literature review of the indications for caesarean section is reported. (4) A literature review of the indications for instrumental delivery is also reported.

Anonymous Patient Answer

What is adverse birth outcomes?

Although the rates of perinatal mortality had decreased in each region in the United States, the number of preterm deliveries and low birthweight babies increased. Poor quality of care during pregnancy, poor birth outcomes and lack of universal health care make public health priorities and must be stressed out when addressing these issues.

Anonymous Patient Answer

Can adverse birth outcomes be cured?

The birth outcomes of disadvantaged mothers do not always improve following changes to their lifestyles or to the delivery unit and provision of adequate postnatal care. The evidence regarding whether postnatal care can affect birth weights of babies of disadvantaged women needs to be carefully examined.

Anonymous Patient Answer

What are the common side effects of writing exercises?

Writing exercises appear to be feasible and well tolerated for pediatric patients with and without severe disabilities who are admitted to neonatal intensive care unit.

Anonymous Patient Answer

Has writing exercises proven to be more effective than a placebo?

Children who participated in writing exercises experienced more improvement in reading speed, vocabulary, and in spelling tests than children who participated in a placebo. Writers' exercises can be an effective method of improving reading skills in children younger than the age of 16.

Anonymous Patient Answer

Have there been any new discoveries for treating adverse birth outcomes?

There are many discoveries for treating complications related to LBW; therefore, the adverse birth outcomes related to LBW still remain problematic. The authors hope to summarize the current knowledge of the medical management of complications related to LBW to raise the awareness of LBW management, and increase support in further scientific investigations.

Anonymous Patient Answer

What does writing exercises usually treat?

The writing exercises were effective in reducing postnatal anxiety and postnatal depression. These were associated with improvements in self-esteem and self-confidence in mothers of preterm infants.

Anonymous Patient Answer

How serious can adverse birth outcomes be?

Of all adverse birth outcomes reported to the NSPQR, 3 in every 10 births resulted in serious illness. The risks associated with the adverse outcomes were most serious when the mother was of younger than 20 years of age, when the baby was born in the first 35 weeks, or if he or she was not born in a health care facility. The risk of obstetric intervention in severe cases was also raised, including induction of labour, Caesarean section and/or instrumental delivery while the number of adverse birth outcomes were increased. The occurrence and frequency of the outcomes highlight the need to improve healthcare of these patients.

Anonymous Patient Answer
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