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Clinical Trials/NCT01542151
NCT01542151
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country72 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy, Prolonged
Sponsor
University of California, San Francisco
Enrollment
72
Locations
1
Primary Endpoint
Birth within 24 hours of induction
Status
Completed
Last Updated
11 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in fatigue scores(Day 1)
  • Morning-evening chronotype(Day 1)
  • St. Mary's Sleep scale(Prebaseline: Baseline - 12-24 hours)
  • Labor and birth satisfaction(Day 2)
  • Length of time to labor intervention(Day 1)
  • Sleep Quality(Prebaseline: Baseline - 30 days)
  • Cesarean rate(Day 1)
  • Change in hand grip strength(Day 1)
  • Neonatal outcomes(Day 1)

Study Sites (1)

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