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Therapeutic Writing for Pregnancy-Related Stress (RESeT Trial)
N/A
Waitlist Available
Led By Tracy A Manuck, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic hypertension not requiring medications
c. Chronic hypertension on medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 7 months per participant and 2 years for entire study
Awards & highlights
RESeT Trial Summary
This trial is testing whether exposure to chronic environmental stress is a risk factor for adverse pregnancy outcomes, and whether a therapeutic writing intervention can help decrease maternal perceived stress and inflammation. Pregnant women at high risk for adverse outcomes who are enrolled in prenatal care at UNC will be recruited for participation.
Who is the study for?
This trial is for high-risk pregnant women under Medicaid or uninsured, aged <18 or >40, with a single pregnancy between 8-20 weeks' gestation. They must be at risk of preterm birth or preeclampsia but without major fetal anomalies. Participants should not have persistent drug/alcohol abuse and must speak English.Check my eligibility
What is being tested?
The study tests if therapeutic writing can reduce stress and inflammation in high-risk pregnant women. It involves randomized assignments to different writing exercises during prenatal visits, with blood samples taken to measure stress markers and placental analysis after delivery.See study design
What are the potential side effects?
Since the intervention involves non-invasive writing exercises, there are no direct physical side effects expected from participating in this clinical trial.
RESeT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure but don't take medication for it.
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I am on medication for long-term high blood pressure.
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I am either younger than 18 or older than 40 years old.
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I am uninsured or have Medicaid insurance.
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My BMI is over 30, indicating obesity.
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I can communicate and consent in English.
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I have type II diabetes and am on insulin.
RESeT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 7 months per participant and 2 years for entire study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 7 months per participant and 2 years for entire study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pro-inflammatory biomarkers in maternal blood by outcome
Change in pro-inflammatory biomarkers in maternal blood by randomization group
Body Weight Changes
+4 moreSecondary outcome measures
Rate of diagnosis of intrauterine growth restriction, using sex-specific curves, by randomization group
Rate of diagnosis of placental abruption by randomization group
Pre-Eclampsia
+4 moreRESeT Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Therapeutic Writing PromptsExperimental Treatment1 Intervention
Participants will be given writing prompts that discuss events that have been perceived as stressful in their lives and how they may or may not have cultivated resilience and coping strategies because of it.
Group II: No WritingActive Control1 Intervention
Participants will not be given writing prompts during their prenatal care. They will be given blank journals that will NOT contain any instructions or writing prompts.
Group III: General Writing PromptsPlacebo Group1 Intervention
Participants will be given writing prompts that discuss "neutral" topics unrelated to their life stress, resilience, or coping.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,027 Total Patients Enrolled
5 Trials studying Pregnancy Complications
13,338 Patients Enrolled for Pregnancy Complications
Tracy A Manuck, MDPrincipal InvestigatorUniversity of North Carolina
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Pregnancy Complications
250 Patients Enrolled for Pregnancy Complications
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently participating in any other clinical trials.I have high blood pressure but don't take medication for it.I have a significant birth defect in my heart, lungs, or brain.My ultrasound showed 'soft markers' like choroid plexus cysts, but no other issues.I am on medication for long-term high blood pressure.I meet at least two moderate risk criteria for my condition.I am either younger than 18 or older than 40 years old.I meet the major/minor criteria and will be assessed for stress and trauma levels.You have previously given birth prematurely or had preeclampsia during a pregnancy with a baby who had genetic abnormalities or serious birth defects.I am a Spanish-speaking woman.If the baby has mild kidney problems, clubfoot, or a cleft lip or palate, they can still participate in the study.You are pregnant and smoke cigarettes.You have experienced a severe condition called pre-eclampsia during a previous pregnancy.My aneuploidy screening showed a high risk without negative confirmation.I am uninsured or have Medicaid insurance.This criterion does not apply to me.You have previously given birth prematurely between 34 and 36.9 weeks.You have previously given birth prematurely between 16 and 33.9 weeks of pregnancy without any medical intervention.You have had a condition called pre-eclampsia during pregnancy, which caused your baby to be delivered earlier than 37 weeks. You may also be excluded if you had a severe case of pre-eclampsia and delivered at any gestational age.If you have any major birth defects or multiple minor birth defects, you will not be able to participate in the study.I am between 8 and 20 weeks pregnant and considered at high risk for complications.I am a woman eligible for this study.My BMI is over 30, indicating obesity.I can communicate and consent in English.I have type II diabetes and am on insulin.I am a woman with at least one high-risk health condition.People of Black race are eligible to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Therapeutic Writing Prompts
- Group 2: General Writing Prompts
- Group 3: No Writing
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives is this clinical trial hoping to attain?
"This clinical trial, which is expected to take an average of 7 months for each participant and 2 years overall, strives to ascertain the alteration in pro-inflammatory biomarkers in maternal blood based on randomization group. Secondary objectives include assessing utilization of professional psychiatric care; preterm birth rate under 37 weeks' gestation by randomization group; as well as preeclampsia diagnosis according to randomized cohorts."
Answered by AI
Are individuals still being enrolled in this trial?
"This specific trial is not currently seeking participants, as evidenced by its last update on September 12th 2022. Nevertheless, 92 alternate studies can be found that are actively recruiting patients at this time."
Answered by AI
Is there an opportunity to participate in this research?
"The requirements for this medical trial stipulate that applicants must experience stress, have no physiological conditions, and be between the ages of 18-50. Regrettably, only 15 patients will be accepted to take part in the study."
Answered by AI
Does this investigation accept geriatric test subjects?
"To be accepted for this clinical trial, individuals must satisfy the age criteria of being over 18 years old and younger than 50."
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