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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539562
• Other study ID #: 17-21855
• Status: Completed
• Start date: September 27, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Labor
• Labor Pain
• Obstetric Labor, Premature

Intervention

Drug:
• Morphine Sulfate and Promethazine
Morphine sulfate and promethazine

Locations

Country	Name	City	State
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Koontz WL, Bishop EH. Management of the latent phase of labor. Clin Obstet Gynecol. 1982 Mar;25(1):111-4. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Time in hours between admission to labor and delivery and complete cervical dilation	Length of admission	1-2 weeks after delivery
Secondary	Time in hours between admission to labor and delivery and birth time	Length of admission	1-2 weeks after delivery
Secondary	Time in hours between complete cervical dilation and birth time	Length of second stage	1-2 weeks after delivery
Secondary	Proportion of women who required induction of labor	Induction of labor	1-2 weeks after delivery
Secondary	Proportion of women who required augmentation of labor	Augmentation of labor	1-2 weeks after delivery
Secondary	Proportion of women who received an epidural	Epidural use	1-2 weeks after delivery
Secondary	Type of delivery	Mode of delivery	1-2 weeks after delivery
Secondary	Proportion of women diagnosed with chorioamnionitis	Presence of maternal infection	1-2 weeks after delivery
Secondary	APGAR scores of neonate	Neonatal clinical assessment	1-2 weeks after birth
Secondary	Umbilical cord gas values	Neonatal laboratory assessment	1-2 weeks after birth
Secondary	Proportion of newborns admitted to Intensive Care Nursery	Neonatal Intensive Care Unit admission	1-2 weeks after birth
Secondary	Neonatal Intensive Care Unit length of stay in days	Length of stay in the Intensive Care Nursery	1-2 weeks after birth
Secondary	Proportion of women with meconium present during labor	Presence of meconium	1-2 weeks after delivery
Secondary	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