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

Not Applicable

Terminated

• Conditions: Pregnancy Related; Elective Induction
• Interventions: Behavioral: Shared decision-making with a Decision-aid; Behavioral: routine shared decision-making

• Registration Number: NCT04052347
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-09
• Study Start: 2019-11-25
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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):

  2. Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)

  3. Cerclage in the index pregnancy

  4. Diabetes mellitus-gestational or pre-gestational

  5. Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)

  6. Hypertension (chronic or pregnancy induced) before enrollment

  7. HIV (human immunodeficiency virus)

  8. Institutionalized individuals (prisoners)

  9. 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

  10. Preterm labor or ruptured membranes before enrollment

  11. Psychiatric disorder (bipolar, depression) on medication

  12. Placenta previa / 3rd trimester bleeding

  13. Renal insufficiency (serum creatinine > 1.5 mg/dL)

  14. Restrictive lung disease

  15. Fetal red blood cell isoimmunization

  16. Seizure disorder on medication

  17. Thyroid disease on medication

  18. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared decision-making with a patient decision-aid	Shared decision-making with a Decision-aid	-
routine shared decision-making	routine shared decision-making	control group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Maternal morbidities	1 week	Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG)
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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States