PainNCT04087317
Vaginal Postpartum Pain Management Protocol Comparison
A study testing Paracetamol 1000 Mg Oral Tablet, Ibuprofen 400Mg Tab and Ibuprofen 400 mg in people with Pain and Post Partum Depression, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Post Partum Depression, Opioid Use
- What is being tested?
- Paracetamol 1000 Mg Oral Tablet, Ibuprofen 400Mg Tab and Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2020to 30 Jul 2022
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women following term vaginal delivery.
Who cannot join
- Under Age 18 years or older than 45 years.
- Women with chronic pain syndrome.
- Women with relative or absolute contraindications for paracetamol or NSAIDs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery
Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
Read the detailed description
More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement.
A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine).
In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
- Conditions
- Pain, Post Partum Depression, Opioid Use, Breast Feeding
- Being tested
- Paracetamol 1000 Mg Oral Tablet, Ibuprofen 400Mg Tab, Ibuprofen 400 mg, MIR
- Medical subject headings
- Pain, Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 1000 Mg Oral TabletDrug
Also called Acetaminophen
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
Ibuprofen 400Mg TabDrug
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
Paracetamol 1000 Mg Oral TabletDrug
Also called Acetaminophen
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
Ibuprofen 400 mgDrug
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
MIRDrug
At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
| Study group | Role | What they receive |
|---|---|---|
| Fixed time interval group. | Experimental | Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). Receives: Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Ibuprofen 400Mg Tab; Drug: MIR |
| 'On-demand' group. | Experimental | Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). Receives: Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Ibuprofen 400 mg; Drug: MIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) score difference in the 24 first hours.
Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
Measured: In the first 24 hours postpartum.
Secondary outcomes (5)
Amount of additional analgesia requirements.
Total amount of additional analgesia up to maternal discharge.
Measured: Up to maternal discharge (5 days)
Total analgesia requirements.
Total amount of analgesics use during 48 hours following a vaginal delivery.
Measured: Up to 48 hours postpartum.
Breastfeeding rate.
The rate of women who breastfeed their newborns and breastfeeding frequency.
Measured: Up to 48 hours postpartum.
Treatments side effects.
Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.
Measured: Up to 48 hours postpartum.
Visual analog scale (VAS) score difference up to maternal discharge.
Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
Measured: At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). up to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented. All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Bachar MD, Rambam Health Care Campus
- Investigators
- Gal Bachar, MD, Principal investigator, Rambam Medical Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087317
- Sponsor's protocol ID
- Rambam Health Care Center.
- Status last verified
- Dec 2023
- First submitted
- 7 Aug 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bachar G, Alter A, Justman N, Buchnik Fater G, Farago N, Ben-David C, Abu-Rass H, Siegler Y, Hajaj A, Landau-Levin M, Zipori Y, Khatib N, Weiner Z, Vitner D. Fixed-time interval vs on-demand oral analgesia after vaginal delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 May;6(5):101372. doi: 10.1016/j.ajogmf.2024.101372. Epub 2024 Apr 5.
PubMed 38583715Deussen 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery
- ClinicalTrials.gov ID
- NCT04087317
- Acronym / sponsor ID
- Rambam Health Care Center.
- Conditions
- Pain, Post Partum Depression, Opioid Use, Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 12 Sep 2019 (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.
Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
Detailed description
More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement.
A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine).
In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented. All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
| Arm | Type | Receives |
|---|---|---|
| Fixed time interval group. | Experimental | Drug: Paracetamol 1000 Mg Oral Tablet, Drug: Ibuprofen 400Mg Tab, Drug: MIRPatients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). |
| 'On-demand' group. | Experimental | Drug: Paracetamol 1000 Mg Oral Tablet, Drug: Ibuprofen 400 mg, Drug: MIRPatients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women following term vaginal delivery.
Key exclusion criteria (3 listed)
- Under Age 18 years or older than 45 years.
- Women with chronic pain syndrome.
- Women with relative or absolute contraindications for paracetamol or NSAIDs.
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 |
|---|---|---|
| Paracetamol 1000 Mg Oral TabletAlso: AcetaminophenThe drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery. | Drug | Fixed time interval group. |
| Ibuprofen 400Mg TabThe drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery. | Drug | Fixed time interval group. |
| Paracetamol 1000 Mg Oral TabletAlso: AcetaminophenThe drug will be administrated after a maternal request, by at least 6 hours apart between dosages. | Drug | 'On-demand' group. |
| Ibuprofen 400 mgThe drug will be administrated after a maternal request, by at least 6 hours apart between dosages. | Drug | 'On-demand' group. |
| MIRAt any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). | Drug | 'On-demand' group., Fixed time interval group. |
Primary outcome
Visual analog scale (VAS) score difference in the 24 first hours.
Time frame: In the first 24 hours postpartum.
Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
5 secondary outcomes
Amount of additional analgesia requirements.
Time frame: Up to maternal discharge (5 days)
Total analgesia requirements.
Time frame: Up to 48 hours postpartum.
Breastfeeding rate.
Time frame: Up to 48 hours postpartum.
Treatments side effects.
Time frame: Up to 48 hours postpartum.
Visual analog scale (VAS) score difference up to maternal discharge.
Time frame: At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). up to 5 days.
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 3 Jan 2024.
- Derived from this study: PubMed 38583715Bachar G, Alter A, Justman N, Buchnik Fater G, Farago N, Ben-David C, Abu-Rass H, Siegler Y, Hajaj A, Landau-Levin M, Zipori Y, Khatib N, Weiner Z, Vitner D. Fixed-time interval vs on-demand oral analgesia after vaginal delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 May;6(5):101372. doi: 10.1016/j.ajogmf.2024.101372. Epub 2024 Apr 5.
- 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.
Gal Bachar, MD principal investigator
Rambam Medical Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol 1000 Mg Oral Tablet, Ibuprofen 400Mg Tab and Ibuprofen 400 mg in people with Pain and Post Partum Depression, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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 3 Jan 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 Israel. 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?
Visual analog scale (VAS) score difference in the 24 first hours. (time frame: In the first 24 hours postpartum.). 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 NCT04087317, which also lists 2 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 3 Jan 2024.