NCT01542151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

3.1 years

First QC Date

January 24, 2012

Last Update Submit

March 24, 2015

Conditions

Pregnancy, Prolonged

Keywords

Labor, inducedSleepFatiguePatient satisfactionCircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Cesarean rate

    Day 1

  • Change in fatigue scores

    Day 1

  • Change in hand grip strength

    Day 1

  • St. Mary's Sleep scale

    Prebaseline: Baseline - 12-24 hours

  • Labor and birth satisfaction

    Day 2

  • +4 more secondary outcomes

Study Arms (2)

Morning

ACTIVE COMPARATOR

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

Other: Time of labor induction

Evening

EXPERIMENTAL

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

Other: Time of labor induction

Interventions

Time of labor inductionOTHER

Assigned time of labor induction - morning or evening

Also known as: Labor, induced
EveningMorning

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant at 40 weeks gestation or more
  • Nulliparous
  • years old or older
  • English or Spanish speaking
  • Healthy maternal status
  • Labor induction able to be scheduled

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Medicall Center

Fresno, California, 93701, United States

Location

MeSH Terms

Conditions

Pregnancy, ProlongedFatiguePatient Satisfaction

Interventions

Labor, Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mary K Barger, PhD

    University of Clifornia, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

March 2, 2012

Study Start

October 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)