Therapeutic Writing to Reduce Stress (RESeT)

This is an interventional supportive care trial for Pregnancy Complications Read More

Inclusion Criteria:

• Women will be prospectively recruited.

  1. 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.
  2. Singleton viable intrauterine pregnancy, with dating confirmed by ultrasound or plans for ultrasound to confirm dating prior to study enrollment
  3. No structural abnormalities or aneuploidy
  4. Ability to communicate in and provide consent in English

  5. Women with at least ONE of the following high risk criteria:

     a. Short cervix by endovaginal ultrasound, measuring <25mm b. Prior spontaneous preterm birth 16.0 - 33.9 weeks' gestation i. Documentation of the prior spontaneous preterm birth in the patient's medical records is desirable but is not required for eligibility.

     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

     OR

  6. Women with at least TWO of the following moderate risk criteria:

     1. Prior preterm birth 34.0-36.9 weeks
     2. Chronic hypertension not requiring medications
     3. History of term pre-eclampsia
     4. Type II diabetes on insulin
     5. Obesity with a BMI >30
     6. Smoking during pregnancy
     7. Black race
     8. Maternal age <18 years old or >40 years old
     9. Nulliparous
     10. Uninsured, or medicaid insurance
  7. Women who meet at least one major or 2 minor inclusion criteria along with the other criteria above will then be screened for high levels of acute and chronic stress and trauma using the Perceived Stress questionnaire to determine final eligibility for the study

Exclusion Criteria:

1. Persistent Illicit drug or alcohol abuse during current pregnancy >12 weeks. Use of tobacco and/or marijuana is not an exclusion. Methadone or suboxone use in an approved treatment program is not an exclusion.
2. Prior preterm birth or preeclampsia was in a pregnancy complicated by fetal aneuploidy or major congenital fetal anomalies in the absence of another pregnancy meeting above inclusion criteria

3. Major congenital anomaly such as major structural deficit of the heart, lungs, or brain or aneuploidy

   1. Mild renal abnormalities, clubfoot, isolated cleft lip/palate, etc. in the fetus are not a reason for exclusion
   2. For a detailed list of major anomalies, see Table 3 - Major Fetal Anomalies / Congenital Malformations, below. Two or more minor anomalies observed together (see Table 2 - Minor Fetal Anomalies / Congenital Malformations) count as a "major" anomaly
   3. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion
   4. If aneuploidy screening is performed, any aneuploidy screen positive test with a risk for aneuploidy greater than 1 in 25 without negative confirmatory definitive aneuploidy testing is reason for exclusion
4. Spanish speaking women
5. Women participating in other intervention-based studies