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

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

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

Study Overview

• Status: Terminated
• Conditions: Pregnancy Related; Elective Induction
• Intervention / Treatment: Behavioral: Shared decision-making with a Decision-aid; Behavioral: routine shared decision-making

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared decision-making with a patient decision-aid	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
Active Comparator: routine shared decision-making; control group	Behavioral: routine shared decision-making; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Maternal morbidities	Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG)	1 week

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-19-0490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No