Early Labor, Labor Pain
Conditions
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.
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.
Interventions
DRUGMorphine Sulfate and Promethazine
Morphine sulfate and promethazine
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of women who were admitted in active labor (6 cm or greater cervical dilation). | 0 hours to 2 weeks | Admission in active labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in hours between being offered therapeutic rest and admission to labor and delivery | 1-2 weeks after delivery | Latency period between being offered therapeutic rest and admission |
| Time in hours between admission to labor and delivery and complete cervical dilation | 1-2 weeks after delivery | Length of admission |
| Time in hours between admission to labor and delivery and birth time | 1-2 weeks after delivery | Length of admission |
| Time in hours between complete cervical dilation and birth time | 1-2 weeks after delivery | Length of second stage |
| Proportion of women who required induction of labor | 1-2 weeks after delivery | Induction of labor |
| Proportion of women who required augmentation of labor | 1-2 weeks after delivery | Augmentation of labor |
| Proportion of women who received an epidural | 1-2 weeks after delivery | Epidural use |
| Time in hours between the start of contractions to being offered therapeutic rest | 1-2 weeks after delivery | Duration of contractions in hours before presenting for rule out labor |
| Proportion of women diagnosed with chorioamnionitis | 1-2 weeks after delivery | Presence of maternal infection |
| APGAR scores of neonate | 1-2 weeks after birth | Neonatal clinical assessment |
| Umbilical cord gas values | 1-2 weeks after birth | Neonatal laboratory assessment |
| Proportion of newborns admitted to Intensive Care Nursery | 1-2 weeks after birth | Neonatal Intensive Care Unit admission |
| Neonatal Intensive Care Unit length of stay in days | 1-2 weeks after birth | Length of stay in the Intensive Care Nursery |
| Proportion of women with meconium present during labor | 1-2 weeks after delivery | Presence of meconium |
| 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. | 1-4 weeks after delivery | Patient satisfaction assessment |
| Type of delivery | 1-2 weeks after delivery | Mode of delivery |
Countries
United States
Outcome results
None listed