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

NCT03539562 | Completed

• 1 other identifier: 17-21855
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Early Labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Time in hours between the start of contractions to being offered therapeutic rest

  1-2 weeks after delivery

• Time in hours between being offered therapeutic rest and admission to labor and delivery

  1-2 weeks after delivery

• Time in hours between admission to labor and delivery and complete cervical dilation

  1-2 weeks after delivery

• Time in hours between admission to labor and delivery and birth time

  1-2 weeks after delivery

• Time in hours between complete cervical dilation and birth time

  1-2 weeks after delivery

Study Arms (2)

Accepted Morphine Sulfate

Patients accepted morphine and promethazine as a method for pain management in early or prodromal labor.

Drug: Morphine Sulfate and Promethazine

Declined Morphine Sulfate

Patients declined morphine and promethazine as a method for pain management in early or prodromal labor.

Interventions

Morphine Sulfate and Promethazine DRUG

Morphine sulfate and promethazine

Also known as: Morphine Sleep

Accepted Morphine Sulfate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (5)

• ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.

  PMID: 15229040 BACKGROUND

• 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.

  PMID: 23471604 BACKGROUND

• 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.

  PMID: 7067192 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 33545440 DERIVED

MeSH Terms

Conditions

Labor Pain; Obstetric Labor, Premature

Interventions

Morphine; Promethazine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propylamines; Amines; Organic Chemicals; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Stephanie L Gaw, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: May 29, 2018
• Study Start: September 27, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (1)