UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
NCT Number: NCT03539562
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.
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Notify Me18 year–55 year
Female
Observational
San Francisco, California, 94158, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Morphine sulfate and promethazine
Other names: Morphine Sleep
Time frame: 0 hours to 2 weeks
Admission in active labor
Time frame: 1-2 weeks after delivery
Duration of contractions in hours before presenting for rule out labor
Time frame: 1-2 weeks after delivery
Latency period between being offered therapeutic rest and admission
Time frame: 1-2 weeks after delivery
Length of admission
Time frame: 1-2 weeks after delivery
Length of admission
Time frame: 1-2 weeks after delivery
Length of second stage
Time frame: 1-2 weeks after delivery
Induction of labor
Time frame: 1-2 weeks after delivery
Augmentation of labor
Time frame: 1-2 weeks after delivery
Epidural use
Time frame: 1-2 weeks after delivery
Mode of delivery
Time frame: 1-2 weeks after delivery
Presence of maternal infection
Time frame: 1-2 weeks after birth
Neonatal clinical assessment
Time frame: 1-2 weeks after birth
Neonatal laboratory assessment
Time frame: 1-2 weeks after birth
Neonatal Intensive Care Unit admission
Time frame: 1-2 weeks after birth
Length of stay in the Intensive Care Nursery
Time frame: 1-2 weeks after delivery
Presence of meconium
Time frame: 1-4 weeks after delivery
Patient satisfaction assessment
University of California, San Francisco
Other
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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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