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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542151
First Posted: March 2, 2012
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention
Pregnancy, Prolonged Other: Time of labor induction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 72
Study Start Date: October 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Labor, induced

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542151


Locations
United States, California
Community Medicall Center
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mary K Barger, PhD University of Clifornia, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01542151     History of Changes
Other Study ID Numbers: TimeIOL
First Submitted: January 24, 2012
First Posted: March 2, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by University of California, San Francisco:
Labor, induced
Sleep
Fatigue
Patient satisfaction
Circadian rhythm

Additional relevant MeSH terms:
Fatigue
Pregnancy, Prolonged
Signs and Symptoms
Pregnancy Complications