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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Labor Pain, Early Labor

Intervention / Treatment
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* Drug: Morphine Sulfate and Promethazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancies between 37w0d and 41w6d gestation Presentation to triage for rule out labor as primary indication and found to be in early labor Offered therapeutic rest by obstetric provider with plan to discharge home after evaluation Exclusion Criteria: Allergy to morphine sulfate or promethazine Being without an attendant to safely transport the patient home Present to triage for other indication (decreased fetal-movement, premature rupture of membranes, hypertension, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Accepted Morphine Sulfate<br>Patients accepted morphine and promethazine as a method for pain management in early or prodromal labor. | Drug: Morphine Sulfate and Promethazine<br>* Morphine sulfate and promethazine<br>* Other names: Morphine Sleep;|
| Declined Morphine Sulfate<br>Patients declined morphine and promethazine as a method for pain management in early or prodromal labor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of women who were admitted in active labor (6 cm or greater cervical dilation). | Admission in active labor | 0 hours to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in hours between the start of contractions to being offered therapeutic rest | Duration of contractions in hours before presenting for rule out labor | 1-2 weeks after delivery | 
| Time in hours between being offered therapeutic rest and admission to labor and delivery | Latency period between being offered therapeutic rest and admission | 1-2 weeks after delivery | 
| Time in hours between admission to labor and delivery and complete cervical dilation | Length of admission | 1-2 weeks after delivery | 
| Time in hours between admission to labor and delivery and birth time | Length of admission | 1-2 weeks after delivery | 
| Time in hours between complete cervical dilation and birth time | Length of second stage | 1-2 weeks after delivery | 
| Proportion of women who required induction of labor | Induction of labor | 1-2 weeks after delivery | 
| Proportion of women who required augmentation of labor | Augmentation of labor | 1-2 weeks after delivery | 
| Proportion of women who received an epidural | Epidural use | 1-2 weeks after delivery | 
| Type of delivery | Mode of delivery | 1-2 weeks after delivery | 
| Proportion of women diagnosed with chorioamnionitis | Presence of maternal infection | 1-2 weeks after delivery | 
| APGAR scores of neonate | Neonatal clinical assessment | 1-2 weeks after birth | 
| Umbilical cord gas values | Neonatal laboratory assessment | 1-2 weeks after birth | 
| Proportion of newborns admitted to Intensive Care Nursery | Neonatal Intensive Care Unit admission | 1-2 weeks after birth | 
| Neonatal Intensive Care Unit length of stay in days | Length of stay in the Intensive Care Nursery | 1-2 weeks after birth | 
| Proportion of women with meconium present during labor | Presence of meconium | 1-2 weeks after delivery | 
| 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. | Patient satisfaction assessment | 1-4 weeks after delivery |