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Completed

NCT Number: NCT01542151

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

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.

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Key information

Conditions

Pregnancy, Prolonged Behavior Fatigue Female Urogenital Diseases and Pregnancy Complications Health Behavior Pathological Conditions, Signs and Symptoms Patient Satisfaction Pregnancy Complications Signs and Symptoms Treatment Adherence and Compliance Urogenital Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community Medicall Center

Fresno, California, 93701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time of labor induction

Other

Assigned time of labor induction - morning or evening

Other names: Labor, induced

Primary outcomes

  1. Birth within 24 hours of induction

    Time frame: Day 1

    Calculate proportion of women delivering within 24 hours of the start of labor induction between the two groups

Secondary outcomes

  1. Cesarean rate

    Time frame: Day 1

    Compare cesarean rates between the two groups

  2. Change in fatigue scores

    Time frame: Day 1

    Differences in Fatigue Visual Analog Scales from admission to active labor between the two groups.

  3. Change in hand grip strength

    Time frame: Day 1

    Differences in change in hand grip strength from admission to active labor between the two groups.

  4. St. Mary's Sleep scale

    Time frame: Prebaseline: Baseline - 12-24 hours

    Differences in St. Mary's Sleep scores on admission between the two groups.

  5. Labor and birth satisfaction

    Time frame: Day 2

    Differences in Labor and Birth Satisfaction between the two groups.

  6. Morning-evening chronotype

    Time frame: Day 1

    Correlation between Horne-Osteberg Morning-Eveningness chronotype and birth within 24 hours of start of induction.

  7. Sleep Quality

    Time frame: 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.

  8. Length of time to labor intervention

    Time frame: 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

  9. Neonatal outcomes

    Time frame: Day 1

    Differences between groups on neonatal outcomes such as 5 minute Apgar scores and admission to neonatal intensive care unit.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 2, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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