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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-27

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Labor Analgesia in the Latent Phrase

NCT00647725

Labor Pain

COMPLETED NA

Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients

NCT03566342

LABOR PAIN

TERMINATED

The Physical Effects of Pain Catastrophizing in Labor

NCT01012466

Pregnancy

COMPLETED

Ropivacaine and Fentanyl for Labor Epidural Initiation

NCT07076368

Pregnancy Labor and Delivery Labor Analgesia

RECRUITING PHASE3

Non-pharmacological Resources in Assisting Labor

NCT01389128

Labour Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain Early Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Accepted Morphine Sulfate

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

Morphine Sulfate and Promethazine

Intervention Type DRUG

Morphine sulfate and promethazine

Declined Morphine Sulfate

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Morphine Sulfate and Promethazine

Morphine sulfate and promethazine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Morphine Sleep

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes