Postpartum PainPhase 4NCT04017442
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
A Phase 4 study testing Preservative Free Morphine and Saline in people with Postpartum Pain and Postpartum Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Pain, Postpartum Depression, Opioid Consumption
- What is being tested?
- Preservative Free Morphine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2019to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women in labor
Who cannot join
- Not a candidate for neuraxial anesthesia
- Patient refusal
- Allergy to morphine
- Patients with chronic pain syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.
Read the detailed description
After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.
- Conditions
- Postpartum Pain, Postpartum Depression, Opioid Consumption
- Being tested
- Preservative Free Morphine, Saline
- Keywords
- Postpartum depression, Postpartum anxiety, Postpartum opioids
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative Free MorphineDrug
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
SalineDrug
Also called Placebo
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Experimental | 2mg preservative free morphine Receives: Drug: Preservative Free Morphine |
| Saline | Placebo comparator | 4 mL preservative free saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption in MME
Quantity of opioid in morphine milligram equivalents (MME) used within 24 hours of delivery.
The conversions from opioids to MME were as follows: 2 mg oral hydromorphone as 8 MME, 5 mg oxycodone 7.5 MME. To convert the PO hydromorphone to MME, IV hydromorphone was converted to morphine with a 4:1 ratio to convert to morphine followed by a 1:3 ratio to convert IV to PO.
Measured: within 24 hours of delivery
Secondary outcomes (4)
Pain Score
Pain Score: Likert full scale 0-10, with higher score indicating more pain
Measured: at 24 hours
Obstetric Quality of Recovery Score (OBSQ10)
OBSQ10 total score 0-100, with higher score indicating better health status
Measured: 24 hours
Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10
Number of Participants with positive EPDS screen in the 6-week post-delivery EPDS defined as a score higher than 10.
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item instrument to assess postpartum depression, with total score from 0-30. Higher score indicates more depressed symptoms.
Measured: up to 6 weeks
Number of Participants With Exclusive Breast Feeding
Participants will respond yes/no as to their breast feeding success and continuation exclusively.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start19 Oct 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, prospective, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017442
- Sponsor's protocol ID
- GCO 18-2789
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2019
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
PubMed 33078388
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04017442
- Acronym / sponsor ID
- GCO 18-2789
- Conditions
- Postpartum Pain, Postpartum Depression, Opioid Consumption
- Keywords
- Postpartum depression, Postpartum anxiety, Postpartum opioids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.
Detailed description
After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, prospective, randomized
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: Preservative Free Morphine2mg preservative free morphine |
| Saline | Placebo comparator | Drug: Saline4 mL preservative free saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women in labor
Key exclusion criteria (4 listed)
- Not a candidate for neuraxial anesthesia
- Patient refusal
- Allergy to morphine
- Patients with chronic pain syndromes
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 |
|---|---|---|
| Preservative Free MorphineAfter delivery of the baby patients will receive via the epidural catheter prior to its removal. | Drug | Morphine |
| SalineAlso: PlaceboAfter delivery of the baby patients will receive via the epidural catheter prior to its removal. | Drug | Saline |
Primary outcome
Opioid Consumption in MME
Time frame: within 24 hours of delivery
Quantity of opioid in morphine milligram equivalents (MME) used within 24 hours of delivery. The conversions from opioids to MME were as follows: 2 mg oral hydromorphone as 8 MME, 5 mg oxycodone 7.5 MME. To convert the PO hydromorphone to MME, IV hydromorphone was converted to morphine with a 4:1 ratio to convert to morphine followed by a 1:3 ratio to convert IV to PO.
4 secondary outcomes
Pain Score
Time frame: at 24 hours
Obstetric Quality of Recovery Score (OBSQ10)
Time frame: 24 hours
Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10
Time frame: up to 6 weeks
Number of Participants With Exclusive Breast Feeding
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33078388Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
- Individual participant dataSharing planned: No
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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.
Daniel Katz, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preservative Free Morphine and Saline in people with Postpartum Pain and Postpartum Depression, run by Icahn School of Medicine at Mount Sinai 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 1 inclusion and 4 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 14 Aug 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Consumption in MME (time frame: within 24 hours of delivery). 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 NCT04017442, which also lists 1 linked publication.
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 14 Aug 2024.