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The effect of Elaeagnus angustifolia fruit extract capsule on childbirth after-pains among multiparous women

Protocol summary

Study aim
Determination of the effect of Elaeagnus angustifolia fruit extract capsule on childbirth after-pains among multiparous women
Design
A randomized clinical trial with control group, in a parallel, three-way, blind, randomized on 105 women in the postpartum period, who were selected as available, and randomization is done using the website www.randomization.com. Each of the groups of Elaeagnus angustifolia fruit extract, placebo and Mefenamic acid are included.
Settings and conduct
People inter the study 2 hours after delivery. In the Elaeagnus angustifolia fruit extract, one capsule of 500 mg of Elaeagnus angustifolia fruit extract and in the placebo group, a placebo is given to the individual every 6 hours to 24 hours, and one hour after each drug dose, their pain will be measured. In the mefenamic acid group, mefenamic acid will be given if necessary according to the routine of Ommolbanin hospital, and the number of mefenamic acid used and their pain will be measured as in other groups. the research unit and the statistical analyst will not know about the codes related to the Elaeagnus angustifolia fruit extract capsule, placebo and mefenamic acid and which group each of the research units are placed in.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: the second to fourth birth. Normal delivery and full term, The baby's weight between 2500-4000 grams, Not to be allergic to Elaeagnus angustifolia, Exclusion Criteria: The impossibility of continuing to breastfeed the baby, Any problem that disturbs the routine care of the mother.
Intervention groups
In the intervention groups, there are Elaeagnus angustifolia fruit extract capsule and placebo (containing Avicel powder) and in the control group there is Mefenamic acid based on routine hospital care.
Main outcome variables
childbirth after-pains

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230608058428N1
Registration date: 2023-06-22, 1402/04/01
Registration timing: prospective

Last update: 2023-06-22, 1402/04/01
Update count: 0
Registration date
2023-06-22, 1402/04/01
Registrant information
Name
Seyedeh Parvin Zabeti Asnad Astaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3524 2981
Email address
zabetiasnadp4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Elaeagnus angustifolia fruit extract capsule on childbirth after-pains among multiparous women
Public title
Evaluation of the effect of Elaeagnus angustifolia extract on after-pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
have the desire to enter the study. age between 18 to 35 years old. At least be literate in reading and writing. The current birth be the second to fourth birth. Normal delivery, singleton and full term. (Based on the ultrasound of the first trimester or last menstrual valid period) The baby be alive and healthy. If there are pains with a score of 4 to 10 based on the pain ruler. Cephalic presentation. The baby's weight should be 2500-4000 grams. (weighing recorded in the baby's file) Not to have any past medical and mental history. (heart disease, chronic Hypertension, and pre-eclampsia, diabetes, kidney and lung disease, autoimmune diseases and all types of neurological and mental diseases) Not to be allergic to Elaeagnus angustifolia. (Symptoms of allergy include: rhinitis, rhinoconjunctivitis, dermatitis) Not to be addicted to drugs, psychotropic substances, alcohol or tobacco. Not to have severe post partum bleeding after delivery.(Bleeding that requires medical measures (other than receiving centocinone) or requiring blood transfer and moving to operating room.) Not having any history of uterine surgery or caesarean section Drug analgesia has not been used to reduce labor pain.(Spinal, Epidural, Entonox gas) Not to have 3 and 4 perineum tears. The first, second, and third stages of labor should be normal.(First stage: no fast or slow progressing labor, no prolonged rupture of membranes (more than 12 hours), second stage: no instrumental labor, no third and fourth degree rupture, third stage: spontaneous exit of the placenta and membranes)
Exclusion criteria:
Not intend to continue the research Mother's refusal to take more than one capsule of Elaeagnus angustifolia or placebo The impossibility of continuing to breastfeed the baby (Due to the death of the baby, hospitalization in NICU) Any problem that disturbs the routine care of the mother.(Transferring the mother to the operating room-early discharge before 24 hours-hemorrhage or any obstetric problems of the mother that require treatment.)
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women for the study are divided into 3 groups of Elaeagnus angustifolia fruit extract capsule, placebo and Mefenamic acid by random allocation and enter the study using the random sequence created by the random number table of the site www.randomization.com. In this way, the created random sequence is written on small sheets and kept in a closed envelope, and when each person chooses, the envelope door is opened and they enter each group based on the code (A, B, C).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind groups, the capsules of Elaeagnus angustifolia fruit extract and placebo and mefenamic acid are provided to the researcher by the pharmacist consultant in similar forms (appearance, color and packaging) with three different codes. Therefore, until the end of the study, the research unit and the statistical analyst will not know about the codes related to the Elaeagnus angustifolia fruit extract capsule, placebo and mefenamic acid and which group each of the research units are placed in.
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, School of Nursing and Midwifery
Street address
School of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.030

Health conditions studied

1

Description of health condition studied
after-pains after normal delivery
ICD-10 code
Z39.2
ICD-10 code description
Encounter for routine postpartum follow-up

Primary outcomes

1

Description
Severity of after pain
Timepoint
After 2 hours after delivery, Elaeagnus angustifolia fruit extract capsule or placebo is given to the mother every 6 hours to 24 hours, and the intensity of after pain is measured one hour after each drug dose.
Method of measurement
Painometer-visual analogue scale, which is one of the parts of the painometer tool, will be used to measure pain intensity.

2

Description
Quality of after pain
Timepoint
After 2 hours after delivery, Elaeagnus angustifolia fruit extract capsule or placebo are given to the mother every 6 hours, and the quality of after pain is measured one hour after receiving each drug dose.
Method of measurement
To evaluate the quality of pain, the word description scale index, which is one of the parts of the painometer tool, will be used.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Elaeagnus angustifolia will be purchased from centers approved by the Faculty of Iranian and Complementary Medicine, and after grinding, it will be soaked in 70% hydroalcoholic solvent for 2 days. Then, the obtained hydroalcoholic extract is filtered and after removing the solvent by placing it in a dryer, the final extract will be obtained. This dried extract is formulated as a capsule of 500 mg of whole elderberry fruit extract and will be given to mothers 2 hours after delivery, every 6 hours to 24 hours.
Category
Treatment - Drugs

2

Description
Intervention group: (The second intervention group) Using a placebo with similar capsules and cans, made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences, the capsules contain Avicel powder, which the research units consume 2 hours after delivery, every 6 hours to 24 hours.
Category
Placebo

3

Description
Control group: In this group, there will be no intervention on the mothers, and they received mefenamic acid capsules as needed (PRN) according to the routine of Ommolbanin Hospital. In this group, as in other groups, the number of capsules consumed and their after-pain measurement will be evaluated one hour after taking the medicine.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Dr masoumeh Mirteimuri
Street address
Bahjat16, Ayatolah Bahjat St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734767
Phone
+98 51 3223 1061
Email
oah@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Kiani
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Parvin Zabeti Asnad Astaneh
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
zabetiAsnadp4001@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Karimifz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Parvin Zabeti Asnad Astaneh
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Doctora crossroad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
zabetiAsnadp4001@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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