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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| '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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol 1000 Mg Oral Tablet | Drug | The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | In the first 24 hours postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of additional analgesia requirements. | Total amount of additional analgesia up to maternal discharge. | Up to maternal discharge (5 days) |
| Total analgesia requirements. | Total amount of analgesics use during 48 hours following a vaginal delivery. |
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Inclusion Criteria:
1. Women following term vaginal delivery.
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Gal Bachar, MD | Rambam Medical Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam | Ramat Yishai | 3009500 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38583715 | Derived | 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. | |
| 33078388 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D019052 | Depression, Postpartum |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011644 | Puerperal Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D013607 | Tablets |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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|
| Ibuprofen 400Mg Tab | Drug | 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 Tablet | Drug | The drug will be administrated after a maternal request, by at least 6 hours apart between dosages. |
|
|
| Ibuprofen 400 mg | Drug | The drug will be administrated after a maternal request, by at least 6 hours apart between dosages. |
|
| MIR | Drug | 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 48 hours postpartum. |
| Breastfeeding rate. | The rate of women who breastfeed their newborns and breastfeeding frequency. | Up to 48 hours postpartum. |
| Treatments side effects. | Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia. | 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). | 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. |
| 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. |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |