Determining the effect Intrauterin gel of Mazo aqueous extract the early postpartum hemorrhage
Design
Clinical trial with control group, parallel groups, triple blind, randomized, phase 3 on 68 pregnant mothers
Settings and conduct
The present study is a triple blind clinical trial (research unit, researcher, statistical analyst) which is performed on 68 pregnant women eligible for research referred for vaginal delivery to Umm AL- Banin Hospital in Mashhad. In order to blind the gel of Mazo aqueous extract and placebo in a similar applicator, it has been coded by pharmacist consulting professor. Research units are divided into intervention and control groups by purposeful sampling and random allocation. In the intervention and control groups, in addition to routine care, an intrauterine gel applicator of Mazo aqueous extract and placebo is prescribed. Bleeding is measured by weighing disposable Droschit and pads before and after using the drug and at the end of the first, second and fourth hours after delivery.
Participants/Inclusion and exclusion criteria
Conditions included: women who have less than 5 deliveries; age:15 to 44 years old; term pregnancy; body mass index less than 30; fetal weight between 2500-4000.
Conditions not included: medical and midwifery problems; water bag ruptured more than 12 hours; maternal temperature more than 38; cesarean section or uterine surgery.
Intervention groups
In the intervention and control groups, in addition to routine care, an intrauterine gel applicator of Mazo aqueous extract and placebo is prescribed.
Main outcome variables
Early postpartum hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210305050583N1
Registration date:2021-03-23, 1400/01/03
Registration timing:prospective
Last update:2021-03-23, 1400/01/03
Update count:0
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
Tayebeh Mollazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mollazadeht982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Intrauterin Gel of aqueous extract of Quercus Infectoria gall on the early postpartum hemorrhage
Public title
Evaluation of intrauterine gel of mazo aqueous extract on postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Persian has informed consent to participate in the study .
Tends to have a normal delivery.
Have a singleton pregnancy with a display of the peak of the head
Maternal body mass index is less than 30
Mathers have no history of anemia HB<7
Has no history of allergies to herbal medicines.
Has no history of medical and obstetric diseases.
Has no history of cesarean section and uterine surgery.
Has a history of giving birth less than 5 times .
Gestational age is between 37-42 weeks and in the active phase labore (4-6cm)
Fetal weight should be estimated between 2500-4000
Water bag rupture should not be more than 12 hours and temperature should not be more than 38
Exclusion criteria:
Persion dose not want to continue participating in the study.
Delivery by cesarean section.
Grade 3or 4 perineal rupture or rupture of uterus and cervix occur.
Quick deliveries.
Have delivery with the device.
Have postpartum hemorrhage more than 500cc.
Placenta out by hand
Age
From 15 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in the maternity ward of Umm AL-Banin Hospital is performed by purposive sampling method based on inclusion and exclusion criteria .Research units are assigned to two groups of intervention and control using random allocation with the sequence created in the randomization website; Mazo and placebo aqueous extract gel has been prepared and packaged in the same way by the pharmacist consulting professor at the Pharmacological Research Center of Medicinal Plants of Mashhad University of Medical Sciences, and the pharmacist consulting professor assigns acode to each group(only the pharmacology consultant is aware ).Based on codes A and B assigned to the two groups, the sequence is created AABAB; to hide the allocation, the method of opaque and sealed envelopes, which are numbered in order, will be used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For blinding, aqueous extract gel gel of Mazo and placebo in similar forms and the same applicators are provided to the researcher. Each applicator has a code that only a pharmacist consultant knows. Individuals with inclusion criteria are grouped according to the codes based on the sequence created and until the end of the study, the research unite, researcher, statistical analyst and delivery agent will not know the codes related to aqueous extract of mazo and placebo.
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
Qureshi Building University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595199
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.099
Health conditions studied
1
Description of health condition studied
postpartum hemorrhage
ICD-10 code
O72
ICD-10 code description
Postpartum hemorrhage
Primary outcomes
1
Description
Postpartum hemorrhage
Timepoint
At the beginning of the intervention, at the end of the first, second, third, fourth and first four hours after delivery.
Method of measurement
By weighing the method of collecting blood bags and disposable drums and pads
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving routine oxytocin, immediately after placenta abruption and utrerine massage an interauterine gel applicator containing 700 mg of aqueous extract of mazo is inserted into uterus through the inner hole of cervix.
Category
Prevention
2
Description
Control group:: In addition to receiving routine oxytocin, immediately after placenta abruption and utrerine massage an interauterine gel applicatoris containing placebo gel is inserted into uterus through the inner hole of cervix.