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

NCT ID: NCT01542151

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-11-30

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.

Conditions

Pregnancy, Prolonged

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Morning

Women randomized to a labor induction in the morning between 0600 and 1000.

Group Type: ACTIVE_COMPARATOR

Time of labor induction

Intervention Type: OTHER

Assigned time of labor induction - morning or evening

Evening

Women randomized to a labor induction begun in the evening between 1700-2100

Group Type: EXPERIMENTAL

Time of labor induction

Intervention Type: OTHER

Assigned time of labor induction - morning or evening

Interventions

Time of labor induction

Assigned time of labor induction - morning or evening

Intervention Type: OTHER

Other Intervention Names

Labor, induced

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary K Barger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Clifornia, San Francisco

Locations

Community Medicall Center

Fresno, California, United States

Countries

United States

Other Identifiers

TimeIOL

Identifier Type: -

Identifier Source: org_study_id