Therapeutic Rest in Early Labor, A Study on Morphine Sleep.



Status:Recruiting
Conditions:Women's Studies, Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 55
Updated:6/2/2018
Start Date:May 1, 2018
End Date:December 31, 2020
Contact:Melanie M Maykin, MD
Email:melanie.maykin@gmail.com
Phone:9253818574

Use our guide to learn which trials are right for you!

This will be a prospective study on 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 and cost effectiveness in these two groups of patients. Half
of the participants will be those who accept morphine and the other half will be those who
decline morphine for pain control.

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 obstetric or neonatal outcomes,
patient satisfaction, or costs of labor admission.

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, to complete a questionnaire
including standard demographic questions and 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. Finally, a cost-effectiveness analysis will be conducted. 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.

Inclusion Criteria:

- Singleton pregnancies between 37w0d and 41w0d gestation

- Presentation to triage for rule out labor as primary indication

- Offered therapeutic rest by obstetric provider with plan to discharge home after
evaluation

Exclusion Criteria:

- Not offered therapeutic rest with morphine sulfate

- Present to triage for other indication (decreased fetal-movement, premature rupture of
membranes, 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.
We found this trial at
1
site
San Francisco, California 94158
Phone: 408-398-3301
?
mi
from
San Francisco, CA
Click here to add this to my saved trials