Summary

for females ages 18-55 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:
Stephanie L Gaw

Description

Summary

This will be a prospective study on 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 and cost effectiveness in these two groups of patients. Half of the participants will be those who accept morphine and the other half will be those who decline morphine for pain control.

Details

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 obstetric or neonatal outcomes, patient satisfaction, or costs of labor admission.

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, to complete a questionnaire including standard demographic questions and 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. Finally, a cost-effectiveness analysis will be conducted. 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.

Keywords

Labor Pain Early Labor Obstetric Labor, Premature Morphine Promethazine Morphine Sulfate Accepted Morphine Sulfate Declined Morphine Sulfate

Eligibility

You can join if…

Open to females ages 18-55

  • 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

You CAN'T join if...

  • 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.

Location

  • UCSF Medical Center at Mission Bay accepting new patients
    San Francisco California 94158 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03539562
Study Type
Observational
Last Updated