Elective Induction, Pregnancy Related
Conditions
Brief summary
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
Interventions
BEHAVIORALShared decision-making with a Decision-aid
A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9
BEHAVIORALroutine shared decision-making
control group
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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): 1. Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma) 2. Cerclage in the index pregnancy 3. Diabetes mellitus-gestational or pre-gestational 4. Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia) 5. Hypertension (chronic or pregnancy induced) before enrollment 6. HIV (human immunodeficiency virus) 7. Institutionalized individuals (prisoners) 8. 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 9. Preterm labor or ruptured membranes before enrollment 10. Psychiatric disorder (bipolar, depression) on medication 11. Placenta previa / 3rd trimester bleeding 12. Renal insufficiency (serum creatinine \> 1.5 mg/dL) 13. Restrictive lung disease 14. Fetal red blood cell isoimmunization 15. Seizure disorder on medication 16. Thyroid disease on medication 17. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite neonatal morbidity | at delivery | 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. |
| Maternal morbidities | 1 week | Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG) |
Countries
United States
Outcome results
None listed