Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas
- Conditions
- Pregnancy, Prolonged
- Interventions
- Other: Time of labor induction
- Registration Number
- NCT01542151
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evening Time of labor induction Women randomized to a labor induction begun in the evening between 1700-2100 Morning Time of labor induction Women randomized to a labor induction in the morning between 0600 and 1000.
- Primary Outcome Measures
Name Time Method Birth within 24 hours of induction Day 1 Calculate proportion of women delivering within 24 hours of the start of labor induction between the two groups
- Secondary Outcome Measures
Name Time Method Cesarean rate Day 1 Compare cesarean rates between the two groups
Change in fatigue scores Day 1 Differences in Fatigue Visual Analog Scales from admission to active labor between the two groups.
Morning-evening chronotype Day 1 Correlation between Horne-Osteberg Morning-Eveningness chronotype and birth within 24 hours of start of induction.
St. Mary's Sleep scale Prebaseline: Baseline - 12-24 hours Differences in St. Mary's Sleep scores on admission between the two groups.
Labor and birth satisfaction Day 2 Differences in Labor and Birth Satisfaction between the two groups.
Length of time to labor intervention 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
Sleep Quality 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.
Change in hand grip strength Day 1 Differences in change in hand grip strength from admission to active labor between the two groups.
Neonatal outcomes Day 1 Differences between groups on neonatal outcomes such as 5 minute Apgar scores and admission to neonatal intensive care unit.
Trial Locations
- Locations (1)
Community Medicall Center
🇺🇸Fresno, California, United States