Clinical trial NCT03539562: Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Official title: Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Early Labor
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting to Labor \& Delivery Triage who meet inclusion criteria and are offered morphine sulfate and promethazine by labor provider for therapeutic rest.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of women who were admitted in active labor (6 cm or greater cervical dilation).
timeFrame: 0 hours to 2 weeks
Secondary outcomes:
measure: Time in hours between the start of contractions to being offered therapeutic rest
timeFrame: 1-2 weeks after delivery
measure: Time in hours between being offered therapeutic rest and admission to labor and delivery
timeFrame: 1-2 weeks after delivery
measure: Time in hours between admission to labor and delivery and complete cervical dilation
timeFrame: 1-2 weeks after delivery
measure: Time in hours between admission to labor and delivery and birth time
timeFrame: 1-2 weeks after delivery
measure: Time in hours between complete cervical dilation and birth time
timeFrame: 1-2 weeks after delivery
measure: Proportion of women who required induction of labor
timeFrame: 1-2 weeks after delivery
measure: Proportion of women who required augmentation of labor
timeFrame: 1-2 weeks after delivery
measure: Proportion of women who received an epidural
timeFrame: 1-2 weeks after delivery
measure: Type of delivery
timeFrame: 1-2 weeks after delivery
measure: Proportion of women diagnosed with chorioamnionitis
timeFrame: 1-2 weeks after delivery
measure: APGAR scores of neonate
timeFrame: 1-2 weeks after birth
measure: Umbilical cord gas values
timeFrame: 1-2 weeks after birth
measure: Proportion of newborns admitted to Intensive Care Nursery
timeFrame: 1-2 weeks after birth
measure: Neonatal Intensive Care Unit length of stay in days
timeFrame: 1-2 weeks after birth
measure: Proportion of women with meconium present during labor
timeFrame: 1-2 weeks after delivery
measure: 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.
timeFrame: 1-4 weeks after delivery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephanie L Gaw, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
citation: Mackeen AD, Fehnel E, Berghella V, Klein T. Morphine sleep in pregnancy. Am J Perinatol. 2014 Jan;31(1):85-90. doi: 10.1055/s-0033-1334448. Epub 2013 Mar 7.
citation: Koontz WL, Bishop EH. Management of the latent phase of labor. Clin Obstet Gynecol. 1982 Mar;25(1):111-4. doi: 10.1097/00003081-198203000-00015.
citation: S G. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, PA: Churchill Livingstone; 2007.
citation: Maykin MM, Ukoha EP, Tilp V, Gaw SL, Lewkowitz AK. Impact of therapeutic rest in early labor on perinatal outcomes: a prospective study. Am J Obstet Gynecol MFM. 2021 May;3(3):100325. doi: 10.1016/j.ajogmf.2021.100325. Epub 2021 Feb 2.