Vaginal Postpartum Pain Management Protocol Comparison

NCT04087317 | Completed

• 1 other identifier: Rambam Health Care Center.
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 vaginal delivery.

Conditions

Pain; Post Partum Depression; Opioid Use; Breast Feeding

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Amount of additional analgesia requirements.

  Up to maternal discharge (5 days)

• Total analgesia requirements.

  Up to 48 hours postpartum.

• Breastfeeding rate.

  Up to 48 hours postpartum.

• Treatments side effects.

  Up to 48 hours postpartum.

• Visual analog scale (VAS) score difference up to maternal discharge.

  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.

Study Arms (2)

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).

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).

Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Ibuprofen 400 mg; Drug: MIR

Interventions

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.

Also known as: Acetaminophen

Fixed time interval group.

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.

Fixed time interval group.

Ibuprofen 400 mg DRUG

The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.

'On-demand' group.

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).

'On-demand' group.; Fixed time interval group.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Women following term vaginal delivery.

You may not qualify if:

• Under Age 18 years or older than 45 years.
• Women with chronic pain syndrome.
• Women with relative or absolute contraindications for paracetamol or NSAIDs.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam

Ramat Yishai, 3009500, Israel

Location

Related Publications (2)

• 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.

  PMID: 38583715 DERIVED

• 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.

  PMID: 33078388 DERIVED

MeSH Terms

Conditions

Pain; Depression, Postpartum; Breast Feeding

Interventions

Acetaminophen; Tablets; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Gal Bachar, MD

  Rambam Medical Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 12, 2019
• Study Start: June 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)