Pregnancy, ProlongedNCT01542151
Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas
A study testing Time of labor induction in people with Pregnancy, Prolonged, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Pregnancy, Prolonged
- What is being tested?
- Time of labor induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Time of labor induction
- Keywords
- Labor, induced, Sleep, Fatigue, Patient satisfaction, Circadian rhythm
- Medical subject headings
- Pregnancy, Prolonged, Fatigue, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time of labor inductionOther
Also called Labor, induced
Assigned time of labor induction - morning or evening
| Study group | Role | What they receive |
|---|---|---|
| Morning | Active comparator | Women randomized to a labor induction in the morning between 0600 and 1000. Receives: Other: Time of labor induction |
| Evening | Experimental | Women randomized to a labor induction begun in the evening between 1700-2100 Receives: Other: Time of labor induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth within 24 hours of induction
Calculate proportion of women delivering within 24 hours of the start of labor induction between the two groups
Measured: Day 1
Secondary outcomes (9)
Cesarean rate
Compare cesarean rates between the two groups
Measured: Day 1
Change in fatigue scores
Differences in Fatigue Visual Analog Scales from admission to active labor between the two groups.
Measured: Day 1
Change in hand grip strength
Differences in change in hand grip strength from admission to active labor between the two groups.
Measured: Day 1
St. Mary's Sleep scale
Differences in St. Mary's Sleep scores on admission between the two groups.
Measured: Prebaseline: Baseline - 12-24 hours
Labor and birth satisfaction
Differences in Labor and Birth Satisfaction between the two groups.
Measured: Day 2
Morning-evening chronotype
Correlation between Horne-Osteberg Morning-Eveningness chronotype and birth within 24 hours of start of induction.
Measured: Day 1
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.
Measured: Prebaseline: Baseline - 30 days
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
Measured: Day 1
Neonatal outcomes
Differences between groups on neonatal outcomes such as 5 minute Apgar scores and admission to neonatal intensive care unit.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, ProlongedStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary K Barger, PhD, Principal investigator, University of Clifornia, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542151
- Sponsor's protocol ID
- TimeIOL
- Status last verified
- Mar 2015
- First submitted
- 24 Jan 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas
- ClinicalTrials.gov ID
- NCT01542151
- Acronym / sponsor ID
- TimeIOL
- Conditions
- Pregnancy, Prolonged
- Keywords
- Labor, induced, Sleep, Fatigue, Patient satisfaction, Circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning | Active comparator | Other: Time of labor inductionWomen randomized to a labor induction in the morning between 0600 and 1000. |
| Evening | Experimental | Other: Time of labor inductionWomen randomized to a labor induction begun in the evening between 1700-2100 |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant at 40 weeks gestation or more
- Nulliparous
- 14 years old or older
- English or Spanish speaking
- Healthy maternal status
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time of labor inductionAlso: Labor, inducedAssigned time of labor induction - morning or evening | Other | Evening, Morning |
Primary outcome
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
9 secondary outcomes
Cesarean rate
Time frame: Day 1
Change in fatigue scores
Time frame: Day 1
Change in hand grip strength
Time frame: Day 1
St. Mary's Sleep scale
Time frame: Prebaseline: Baseline - 12-24 hours
Labor and birth satisfaction
Time frame: Day 2
Morning-evening chronotype
Time frame: Day 1
Sleep Quality
Time frame: Prebaseline: Baseline - 30 days
Length of time to labor intervention
Time frame: Day 1
Neonatal outcomes
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary K Barger, PhD principal investigator
University of Clifornia, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time of labor induction in people with Pregnancy, Prolonged, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth within 24 hours of induction (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.