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Covid related
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared decision-making with a patient decision-aid | Experimental |
| |
| routine shared decision-making | Active Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision-making with a Decision-aid | Behavioral | A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| routine shared decision-making | Behavioral | control group |
|
| Maternal morbidities | Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG) | 1 week |