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

Study Overview
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Brief Summary
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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

Official Title
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Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks: A Randomized Trial (DAWN Trial)

Conditions
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Pregnancy Related, Elective Induction

Intervention / Treatment
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* Behavioral: Shared decision-making with a Decision-aid
* Behavioral: routine shared decision-making


Participation Criteria
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Eligibility Criteria
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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): Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma) Cerclage in the index pregnancy Diabetes mellitus-gestational or pre-gestational Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia) Hypertension (chronic or pregnancy induced) before enrollment HIV (human immunodeficiency virus) Institutionalized individuals (prisoners) 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 Preterm labor or ruptured membranes before enrollment Psychiatric disorder (bipolar, depression) on medication Placenta previa / 3rd trimester bleeding Renal insufficiency (serum creatinine > 1.5 mg/dL) Restrictive lung disease Fetal red blood cell isoimmunization Seizure disorder on medication Thyroid disease on medication 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared decision-making with a patient decision-aid<br> | Behavioral: Shared decision-making with a Decision-aid<br>* A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9<br>|
| Active Comparator: routine shared decision-making<br>control group | Behavioral: routine shared decision-making<br>* control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid | Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite neonatal morbidity | Composite neonatal morbidity among (CNM) is any of the following: 1) Apgar score < 7 at 5 min, 2) umbilical arterial pH < 7.00, 3) intraventricular hemorrhage grade III or IV, 4) periventricular leukomalacia, 5) intubation for over 24 hrs, 6) necrotizing enterocolitis grade 2 or 3, 7) stillbirth or 8) death within 28 days of birth. | at delivery | 
| Maternal morbidities | Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG) | 1 week |