Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks (DAWN)

The University of Texas System (UT)

Status: Terminated

Conditions: Pregnancy Related; Elective Induction

Treatments: Behavioral: routine shared decision-making; Behavioral: Shared decision-making with a Decision-aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04052347

HSC-MS-19-0490

Details and patient eligibility

About

The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks

Enrollment: 2 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Low-risk nulliparous women- no previous pregnancy > 23 weeks
• 18-50 years of age
• Singleton gestation
• Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.

Exclusion criteria

• 1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):

  2. Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)

  3. Cerclage in the index pregnancy

  4. Diabetes mellitus-gestational or pre-gestational

  5. Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)

  6. Hypertension (chronic or pregnancy induced) before enrollment

  7. HIV (human immunodeficiency virus)

  8. Institutionalized individuals (prisoners)

  9. Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death

  10. Preterm labor or ruptured membranes before enrollment

  11. Psychiatric disorder (bipolar, depression) on medication

  12. Placenta previa / 3rd trimester bleeding

  13. Renal insufficiency (serum creatinine > 1.5 mg/dL)

  14. Restrictive lung disease

  15. Fetal red blood cell isoimmunization

  16. Seizure disorder on medication

  17. Thyroid disease on medication

  18. Body Mass Index (BMI) above 40 kg/m 3. Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects 4. Unable to understand consent in English or Spanish

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 2 patient groups

Shared decision-making with a patient decision-aid

Experimental group

Treatment:

Behavioral: Shared decision-making with a Decision-aid

routine shared decision-making

Active Comparator group

Description:

control group

Treatment:

Behavioral: routine shared decision-making