Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas

This randomized clinical trial will examine if there are any differences between post-dates inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the evening for first-time mothers. Sleep and fatigue measures will be measured to see if they differ by time of induction. Other measures will include the rate of births within 24 hours of admission, length of labor, use of labor analgesics, and method of delivery.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Prolonged
• Intervention / Treatment: Other: Time of labor induction

Detailed Description

Randomized clinical trial of first-time pregnant women requiring post-dates induction (induction after 40 weeks gestation). Women will be randomized to a labor induction time in the morning or the evening. On hospital admission once women have signed the study consent, they will complete sleep questionnaires and a fatigue assessment. Fatigue and sleep time assessments will subsequently done by the study subject every 4 hours until women enter active labor. At the onset of active labor, assessments will stop. Labor outcomes and patient satisfaction will be obtained once women deliver.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93701
      • Community Medicall Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant at 40 weeks gestation or more
• Nulliparous
• 14 years old or older
• English or Spanish speaking
• Healthy maternal status
• Labor induction able to be scheduled

Exclusion Criteria:

• Less than 40 weeks gestation
• Multiparous
• Younger than 14 years old
• Not able to speak or write in English or Spanish
• Fetal or maternal status requires immediate induction

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morning; Women randomized to a labor induction in the morning between 0600 and 1000.	Other: Time of labor induction; Assigned time of labor induction - morning or evening; Other Names: Labor, induced
Experimental: Evening; Women randomized to a labor induction begun in the evening between 1700-2100	Other: Time of labor induction; Assigned time of labor induction - morning or evening; Other Names: Labor, induced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth within 24 hours of induction	Calculate proportion of women delivering within 24 hours of the start of labor induction between the two groups	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean rate	Compare cesarean rates between the two groups	Day 1
Change in fatigue scores	Differences in Fatigue Visual Analog Scales from admission to active labor between the two groups.	Day 1
Change in hand grip strength	Differences in change in hand grip strength from admission to active labor between the two groups.	Day 1
St. Mary's Sleep scale	Differences in St. Mary's Sleep scores on admission between the two groups.	Prebaseline: Baseline - 12-24 hours
Labor and birth satisfaction	Differences in Labor and Birth Satisfaction between the two groups.	Day 2
Morning-evening chronotype	Correlation between Horne-Osteberg Morning-Eveningness chronotype and birth within 24 hours of start of induction.	Day 1
Sleep Quality	Correlation between sleep quality in the one month prior to admission measured with the Pittsburgh Sleep Quality Index and birth within 24 hours of start of induction.	Prebaseline: Baseline - 30 days
Length of time to labor intervention	Measure differences between groups between length of time from admission to different labor interventions e.g., rupture of membranes, analgesia - IV or epidural	Day 1
Neonatal outcomes	Differences between groups on neonatal outcomes such as 5 minute Apgar scores and admission to neonatal intensive care unit.	Day 1

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Mary K Barger, PhD, University of Clifornia, San Francisco

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Patient satisfaction; Fatigue; Sleep; Circadian rhythm; Labor, induced
• Additional Relevant MeSH Terms: Pregnancy Complications; Fatigue; Pregnancy, Prolonged
• Other Study ID Numbers: TimeIOL