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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01542151
First received: January 24, 2012
Last updated: December 14, 2012
Last verified: December 2012
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Compare cesarean rates between the two groups

  • Change in fatigue scores [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Differences in Fatigue Visual Analog Scales from admission to active labor between the two groups.

  • Change in hand grip strength [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Differences in St. Mary's Sleep scores on admission between the two groups.

  • Labor and birth satisfaction [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Differences in Labor and Birth Satisfaction between the two groups.

  • Morning-evening chronotype [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Correlation between Horne-Osteberg Morning-Eveningness chronotype and birth within 24 hours of start of induction.

  • Sleep Quality [ Time Frame: Prebaseline: Baseline - 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Differences between groups on neonatal outcomes such as 5 minute Apgar scores and admission to neonatal intensive care unit.


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   14 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542151

Contacts
Contact: Mary K Barger, PhD 415-476-0339 mary.barger@nursing.ucsf.edu
Contact: Kathyryn A Lee, PhD 415-476-4442 kathy.lee@nursing.ucsf.edu

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01542151     History of Changes
Other Study ID Numbers: TimeIOL
Study First Received: January 24, 2012
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014