Labor PainNCT03539562
Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
An observational study of Labor Pain and Early Labor, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Early Labor
- What is being tested?
- Morphine Sulfate and Promethazine
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2017to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
About this study
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.
Read the detailed 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.
- Conditions
- Labor Pain, Early Labor
- Being tested
- Morphine Sulfate and Promethazine
- Medical subject headings
- Labor Pain, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine Sulfate and PromethazineDrug
Also called Morphine Sleep
Morphine sulfate and promethazine
| Study group | Role | What they receive |
|---|---|---|
| Accepted Morphine Sulfate | Patients accepted morphine and promethazine as a method for pain management in early or prodromal labor. Receives: Drug: Morphine Sulfate and Promethazine | |
| Declined Morphine Sulfate | Patients declined morphine and promethazine as a method for pain management in early or prodromal labor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of women who were admitted in active labor (6 cm or greater cervical dilation).
Admission in active labor
Measured: 0 hours to 2 weeks
Secondary outcomes (16)
Time in hours between the start of contractions to being offered therapeutic rest
Duration of contractions in hours before presenting for rule out labor
Measured: 1-2 weeks after delivery
Time in hours between being offered therapeutic rest and admission to labor and delivery
Latency period between being offered therapeutic rest and admission
Measured: 1-2 weeks after delivery
Time in hours between admission to labor and delivery and complete cervical dilation
Length of admission
Measured: 1-2 weeks after delivery
Time in hours between admission to labor and delivery and birth time
Length of admission
Measured: 1-2 weeks after delivery
Time in hours between complete cervical dilation and birth time
Length of second stage
Measured: 1-2 weeks after delivery
Proportion of women who required induction of labor
Induction of labor
Measured: 1-2 weeks after delivery
Proportion of women who required augmentation of labor
Augmentation of labor
Measured: 1-2 weeks after delivery
Proportion of women who received an epidural
Epidural use
Measured: 1-2 weeks after delivery
Type of delivery
Mode of delivery
Measured: 1-2 weeks after delivery
Proportion of women diagnosed with chorioamnionitis
Presence of maternal infection
Measured: 1-2 weeks after delivery
APGAR scores of neonate
Neonatal clinical assessment
Measured: 1-2 weeks after birth
Umbilical cord gas values
Neonatal laboratory assessment
Measured: 1-2 weeks after birth
Proportion of newborns admitted to Intensive Care Nursery
Neonatal Intensive Care Unit admission
Measured: 1-2 weeks after birth
Neonatal Intensive Care Unit length of stay in days
Length of stay in the Intensive Care Nursery
Measured: 1-2 weeks after birth
Proportion of women with meconium present during labor
Presence of meconium
Measured: 1-2 weeks after delivery
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
Measured: 1-4 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start27 Sep 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie L Gaw, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539562
- Sponsor's protocol ID
- 17-21855
- Status last verified
- Jul 2020
- First submitted
- 27 Feb 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
PubMed 15229040Mackeen 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.
PubMed 23471604Koontz 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.
PubMed 7067192S G. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, PA: Churchill Livingstone; 2007.
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.
PubMed 33545440
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
- ClinicalTrials.gov ID
- NCT03539562
- Acronym / sponsor ID
- 17-21855
- Conditions
- Labor Pain, Early Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accepted Morphine Sulfate | – | Drug: Morphine Sulfate and PromethazinePatients accepted morphine and promethazine as a method for pain management in early or prodromal labor. |
| Declined Morphine Sulfate | – | –Patients declined morphine and promethazine as a method for pain management in early or prodromal labor. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine Sulfate and PromethazineAlso: Morphine SleepMorphine sulfate and promethazine | Drug | Accepted Morphine Sulfate |
Primary outcome
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
16 secondary outcomes
Time in hours between the start of contractions to being offered therapeutic rest
Time frame: 1-2 weeks after delivery
Time in hours between being offered therapeutic rest and admission to labor and delivery
Time frame: 1-2 weeks after delivery
Time in hours between admission to labor and delivery and complete cervical dilation
Time frame: 1-2 weeks after delivery
Time in hours between admission to labor and delivery and birth time
Time frame: 1-2 weeks after delivery
Time in hours between complete cervical dilation and birth time
Time frame: 1-2 weeks after delivery
Proportion of women who required induction of labor
Time frame: 1-2 weeks after delivery
Proportion of women who required augmentation of labor
Time frame: 1-2 weeks after delivery
Proportion of women who received an epidural
Time frame: 1-2 weeks after delivery
Type of delivery
Time frame: 1-2 weeks after delivery
Proportion of women diagnosed with chorioamnionitis
Time frame: 1-2 weeks after delivery
APGAR scores of neonate
Time frame: 1-2 weeks after birth
Umbilical cord gas values
Time frame: 1-2 weeks after birth
Proportion of newborns admitted to Intensive Care Nursery
Time frame: 1-2 weeks after birth
Neonatal Intensive Care Unit length of stay in days
Time frame: 1-2 weeks after birth
Proportion of women with meconium present during labor
Time frame: 1-2 weeks after delivery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 15229040ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
- Background: PubMed 23471604Mackeen 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.
- Background: PubMed 7067192Koontz 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.
- BackgroundS G. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, PA: Churchill Livingstone; 2007.
- Derived from this study: PubMed 33545440Maykin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie L Gaw, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain and Early Labor, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of women who were admitted in active labor (6 cm or greater cervical dilation). (time frame: 0 hours to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539562, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.