Status:
TERMINATED
Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Pregnancy Related
Elective Induction
Eligibility:
FEMALE
18-50 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04052347
Start Date
November 25 2019
End Date
December 1 2020
Last Update
February 24 2021
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030