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

Pregnancy, Prolonged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542151
• Other study ID #: TimeIOL
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: March 24, 2015
• Start date: October 2011
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pregnancy, Prolonged

Intervention

Other:
• Time of labor induction
Assigned time of labor induction - morning or evening

Locations

Country	Name	City	State
United States	Community Medicall Center	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cesarean rate	Compare cesarean rates between the two groups	Day 1	No
Secondary	Change in fatigue scores	Differences in Fatigue Visual Analog Scales from admission to active labor between the two groups.	Day 1	No
Secondary	Change in hand grip strength	Differences in change in hand grip strength from admission to active labor between the two groups.	Day 1	No
Secondary	St. Mary's Sleep scale	Differences in St. Mary's Sleep scores on admission between the two groups.	Prebaseline: Baseline - 12-24 hours	No
Secondary	Labor and birth satisfaction	Differences in Labor and Birth Satisfaction between the two groups.	Day 2	No
Secondary	Morning-evening chronotype	Correlation between Horne-Osteberg Morning-Eveningness chronotype and birth within 24 hours of start of induction.	Day 1	No
Secondary	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	No
Secondary	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	No
Secondary	Neonatal outcomes	Differences between groups on neonatal outcomes such as 5 minute Apgar scores and admission to neonatal intensive care unit.	Day 1	No