Determining the effect of evening primrose oil capsule on postpartum pain in multiparous women
Design
The clinical trial will be a parallel (placebo and control groups), triple-blind, randomized, phase 3 study on 90 pregnant women. Random number table will be used for randomization.
Settings and conduct
This study will be performed in Amolbinin Hospital in Mashhad. In both intervention and placebo groups, post delivery pain will be measured. The first dose of the drug will be given at least two hours after delivery. The pain will be measured one hour after the intervention. The two groups will receive the capsules 4 times every 8 hours. At each intervention, the pain will be measured and recorded one hour before and one hour after. The control group will receive routine painkillers if pain is expressed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-35 years old, single pregnancy; gestational age 37-42 weeks, infant weight 4000-2500 grams, normal delivery; gravid 2-5, no anesthesia, no previous uterine surgery, second and third stage of normal delivery, no grade 3 and 4 rupture , Pain intensity 4 and more
Exclusion criteria: Pain relief, allergy to evening primrose, serious side effects
Intervention groups
Intervention group: evening primrose oil capsules. Control group: routine care and 500 mg acetaminophen for pain if requested
Main outcome variables
postpartum pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210217050394N1
Registration date:2021-03-08, 1399/12/18
Registration timing:prospective
Last update:2021-03-08, 1399/12/18
Update count:0
Registration date
2021-03-08, 1399/12/18
Registrant information
Name
Maryam Amin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 7082
Email address
aminm982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-07-16, 1400/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of evening primrose oil capsules on postpartum pain in multiparous women
Public title
Evaluation of the effect of evening primrose oil capsules on postpartum pain in multiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
mother age between 18-35 years
singleton pregnancy with gestational age 37-42 weeks
normal delivery
live and seemingly healthy baby
baby weight between 4000-2500 grams
Normal delivery gravid 3-5
No use of narcotics and spinal and epidural anesthesia during labor
No cesarean section or previous uterine surgery
The second and third stages of normal delivery
Absence of medical disease and no grade 3 and 4 perineal and vaginal tears
Lack of sensitivity to medicinal plants and acetaminophen
Start breastfeeding until the first two hours after delivery and continue breastfeeding
Pain intensity (based on visual scale) 4 and more within 2 hours after delivery
Exclusion criteria:
The mother's unwillingness to participation
Allergy to medicinal plants
Medical and midwifery problems
First pregnancy
Multiplication
Mother age should not be between 18-35
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in the midwifery clinic of Umm Al-Banin hospital will be done in an easy method, based on the inclusion and exclusion criteria, and using a simple randomization method, random allocation of samples will be done in different groups. Randomization method will be as follow: It is performed that the assignment sequence will be written before the beginning of the research. Given that 3 groups will be studied and each letter will be assigned to a group (A evening primrose capsule, B placebo and C control group with routine care). Randomization will be performed using Research Randomizer software, then inside the sealed and opaque packages, the type of intervention will be written based on the allocation sequence and packages will be numbered.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Capsules will be encoded by the pharmacist. The capsules will be divided and numbered in opaque and sealed envelopes. Researchers and mothers will be unaware of group codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.083
Health conditions studied
1
Description of health condition studied
Postpartum pain
ICD-10 code
Z39
ICD-10 code description
Encounter for maternal postpartum care and examination
Primary outcomes
1
Description
Postpartum pain in multiparous women
Timepoint
Beginning and end of the study and during the first 24 hours of labor - every 8 hours - one hour before and one hour after the intervention.
Method of measurement
McGill Pain Questionnaire and Visual Pain Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1000 mg evening primrose oil capsule and made by Barij Essential Oil Company, available in the market, based on previous studies in the field of gynecology and obstetrics and with the advice of a pharmacist, its number and amount of use will be determined and considered for intervention at least 2 hours after delivery. The first dose will be given and the pain will be measured and recorded again one hour after taking the medicine. The intervention group will receive the capsule 4 times every 8 hours. At each intervention, pain intensity will be measured and recorded one hour before and one hour after. One hour after each intervention, if the pain will persist and the mothers request painkillers, a 500 mg acetaminophen tablet is given and recorded.
Category
Treatment - Drugs
2
Description
Placebo group: 1000 mg capsule containing paraffin, very similar to evening primrose capsule, at least 2 hours after delivery, the first dose will be given and one hour after taking the drug, the pain will be measured and recorded again. The group will receive the capsule 4 times every 8 hours. At each intervention, pain intensity will be measured and recorded one hour before and one hour after. One hour after each intervention, if the pain will persist and the mother requests painkillers, an acetaminophen 500 mg tablet is given and recorded.
Category
Treatment - Drugs
3
Description
Control group: In the control group, no intervention will be performed and if pain is expressed, they will receive routine analgesia (acetaminophen 500 mg).