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

Stopped early · Not applicable

Conditions studied: Pregnancy Related, Elective Induction

In brief

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

Key facts

Study ID

NCT04052347

Run by

The University of Texas Health Science Center, Houston

People needed

2

Starts

2019-11-25

Expected to finish

2020-12-01

Last updated by the study team

2021-02-24

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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