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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: Birth within 24 hours of induction [ Time Frame: Day 1 ]

Calculate proportion of women delivering within 24 hours of the start of labor induction between the two groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: January 24, 2012
Date Started: October 2011
Date Completion:
Last Updated: March 24, 2015
Last Verified: March 2015