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Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539562
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This will be a prospective study on labor characteristics, and obstetric and neonatal outcomes in women who accept and women who decline morphine as a form of pain management in labor. The study will also investigate patient satisfaction with this form of analgesia. The participants will be those who accept morphine and promethazine and those who decline morphine and promethazine for pain control.

Condition or disease Intervention/treatment
Labor Pain Early Labor Drug: Morphine Sulfate

Detailed Description:

Objective: Therapeutic rest in labor involves administration of parenteral analgesics in early or prodromal labor to relieve the patient's discomfort and allow for progression of labor while the patient rests. No prospective studies exist which examine the safety and clinical utility of therapeutic rest in early labor, and no published studies examine the potential benefits of therapeutic rest from the perspective of either patient satisfaction or cost-effectiveness. The investigators aim to determine whether therapeutic rest using morphine and promethazine is associated with variations in labor characteristics, or obstetric or neonatal outcomes as well as patient satisfaction with this form of pain management.

Methods: This will be a prospective cohort study. Women who are eligible for therapeutic rest (reactive non-stress test, normal amniotic fluid, in prodromal or early labor as defined by obstetric provider, and plan to discharge home after evaluation) will be recruited for the study. Participants will receive routine obstetric care by providers who are unaware of patient enrollment. A research assistant will then approach all participants in the postpartum period, prior to discharge from the hospital or with a phone call if permitted by the patient, to complete a questionnaire including patient satisfaction items. Chart review will be performed to determine differences in hospital stay and common obstetric and neonatal outcomes to compare these data among women who do and do not choose to receive therapeutic rest. These results will provide insight into a common clinical practice, helping to not only guide management at institutions where therapeutic rest is commonly utilized but also potentially encourage its initiation at hospitals were therapeutic rest is not available.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Accepted Morphine Sulfate
Patients accepted morphine and promethazine as a method for pain management in early or prodromal labor.
Drug: Morphine Sulfate
Morphine sulfate and promethazine
Other Name: Morphine Sleep

Declined Morphine Sulfate
Patients declined morphine and promethazine as a method for pain management in early or prodromal labor.



Primary Outcome Measures :
  1. The proportion of women who were admitted in active labor (6 cm or greater cervical dilation). [ Time Frame: 0 hours to 2 weeks ]
    Admission in active labor


Secondary Outcome Measures :
  1. Time in hours between the start of contractions to being offered therapeutic rest [ Time Frame: 1-2 weeks after delivery ]
    Duration of contractions in hours before presenting for rule out labor

  2. Time in hours between being offered therapeutic rest and admission to labor and delivery [ Time Frame: 1-2 weeks after delivery ]
    Latency period between being offered therapeutic rest and admission

  3. Time in hours between admission to labor and delivery and complete cervical dilation [ Time Frame: 1-2 weeks after delivery ]
    Length of admission

  4. Time in hours between admission to labor and delivery and birth time [ Time Frame: 1-2 weeks after delivery ]
    Length of admission

  5. Time in hours between complete cervical dilation and birth time [ Time Frame: 1-2 weeks after delivery ]
    Length of second stage

  6. Proportion of women who required induction of labor [ Time Frame: 1-2 weeks after delivery ]
    Induction of labor

  7. Proportion of women who required augmentation of labor [ Time Frame: 1-2 weeks after delivery ]
    Augmentation of labor

  8. Proportion of women who received an epidural [ Time Frame: 1-2 weeks after delivery ]
    Epidural use

  9. Type of delivery [ Time Frame: 1-2 weeks after delivery ]
    Mode of delivery

  10. Proportion of women diagnosed with chorioamnionitis [ Time Frame: 1-2 weeks after delivery ]
    Presence of maternal infection

  11. APGAR scores of neonate [ Time Frame: 1-2 weeks after birth ]
    Neonatal clinical assessment

  12. Umbilical cord gas values [ Time Frame: 1-2 weeks after birth ]
    Neonatal laboratory assessment

  13. Proportion of newborns admitted to Intensive Care Nursery [ Time Frame: 1-2 weeks after birth ]
    Neonatal Intensive Care Unit admission

  14. Neonatal Intensive Care Unit length of stay in days [ Time Frame: 1-2 weeks after birth ]
    Length of stay in the Intensive Care Nursery

  15. Proportion of women with meconium present during labor [ Time Frame: 1-2 weeks after delivery ]
    Presence of meconium

  16. Patient responses (yes or no) to a 4-question survey conducted after delivery to determine satisfaction with morphine and promethazine as a form of therapeutic rest. [ Time Frame: 1-4 weeks after delivery ]
    Patient satisfaction assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women presenting to Labor & Delivery Triage who meet inclusion criteria and are offered morphine sulfate by labor provider for therapeutic rest.
Criteria

Inclusion Criteria:

  • Singleton pregnancies between 37w0d and 41w0d gestation
  • Presentation to triage for rule out labor as primary indication
  • Offered therapeutic rest by obstetric provider with plan to discharge home after evaluation

Exclusion Criteria:

  • Not offered therapeutic rest with morphine sulfate
  • Present to triage for other indication (decreased fetal-movement, premature rupture of membranes, etc.)
  • Multiple gestation
  • Known fetal anomaly
  • Placenta previa, active maternal Herpes Simplex Virus disease, or any other contraindication to vaginal delivery
  • Recommendation for direct admission to L&D for maternal or fetal indication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539562


Locations
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United States, California
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Stephanie L Gaw, MD, PhD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03539562    
Other Study ID Numbers: 17-21855
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents