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OpenTrials
Completed

NCT Number: NCT03539562

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine Sulfate and Promethazine

Drug

Morphine sulfate and promethazine

Other names: Morphine Sleep

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 29, 2018
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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