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

• ClinicalTrials.gov Identifier: NCT03539562
• Recruitment Status: Completed
• First Posted: May 29, 2018
• Last Update Posted: July 29, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment
Labor Pain; Early Labor	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 Design

• Study Type: Observational
• Actual Enrollment: 82 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
• Actual Study Start Date: September 27, 2017
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: April 1, 2020

Groups and Cohorts

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 Name: Morphine Sleep
Declined Morphine Sulfate; Patients declined morphine and promethazine as a method for pain management in early or prodromal labor.

Outcome Measures

Primary Outcome Measures :

1. The proportion of women who were admitted in active labor (6 cm or greater cervical dilation). [ Time Frame: 0 hours to 2 weeks ]
   Admission in active labor

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• 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.

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.

Contacts and Locations

Locations

United States, California

UCSF Medical Center at Mission Bay

San Francisco, California, United States, 94158

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

More Information

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.

S G. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, PA: Churchill Livingstone; 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03539562
• Other Study ID Numbers: 17-21855
• First Posted: May 29, 2018
• Last Update Posted: July 29, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obstetric Labor, Premature; Labor Pain; Pain; Neurologic Manifestations; Obstetric Labor Complications; Pregnancy Complications; Promethazine; Diphenhydramine; Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antipruritics; Dermatologic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Anesthetics, Local; Anesthetics; Antiemetics; Autonomic Agents