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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01542151
Other study ID # TimeIOL
Secondary ID
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


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
See also
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Not yet recruiting NCT02680093 - Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth. N/A