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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Early Labor
• Intervention / Treatment: Drug: Morphine Sulfate and Promethazine

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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF Medical Center at Mission Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Accepted Morphine Sulfate; Patients accepted morphine and promethazine as a method for pain management in early or prodromal labor.	Drug: Morphine Sulfate and Promethazine; Morphine sulfate and promethazine; Other Names: Morphine Sleep
Declined Morphine Sulfate; Patients declined morphine and promethazine as a method for pain management in early or prodromal labor.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Stephanie L Gaw, MD, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
• 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.
• 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.
• S G. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, PA: Churchill Livingstone; 2007.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pregnancy Complications; Obstetric Labor Complications; Labor Pain; Obstetric Labor, Premature; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Morphine
• Other Study ID Numbers: 17-21855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No