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

Pregnancy Related Clinical Trial

— DAWN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04052347
• Other study ID #: HSC-MS-19-0490
• Status: Terminated
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Elective Induction
• Pregnancy Related

Intervention

Behavioral:
• Shared 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
• routine shared decision-making
control group

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Maternal morbidities	Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG)	1 week