Comparison the effect of rectal suppository of Plantago and Anethum graveolens (Dill) on postpartum hemorrhage (PPH) rate in women at risk of bleeding
Design
The present study is a randomized, triple blind clinical trial with control group and parallel group design, study phase 3 which will be performed on 105 eligible pregnant women.
Settings and conduct
The present study is a triple blind clinical trial (research unit, researcher, and statistician) that is performed on 105 pregnant women who are eligible for vaginal delivery admitted to Umm al-Binin Hospital in Mashhad. The research units are randomly selected and divided into 2 intervention and 1 control groups. In the control group, routine care is taken. In the intervention groups, in addition to routine care, administration of rectal plantago supp and dill sid supp is carried. The amount of blood will be measured through weighing disposable pads before and after using the drug and at the end of the first, 2th and 4th hours of delivery.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Term pregnancy, normal delivery, a score equal to or greater than 10% of the prediction PPH nomogram. Non Inclusion criteria: medical illness, cesarean section or surgery on the uterus, rupture grade 3 and 4, occurrence of labor complications during labor active phase.
Intervention groups
Intervention group 1: Prescription of rectal plantago supp immediately after expulsion of placenta in addition to routine treatment.
Intervention group 2: Prescription of dill rectal supp immediately after expulsion of placenta in addition to routine treatment.
Control group: Oxytocin infusion immediately after expulsion of placenta
Main outcome variables
Postpartum hemorrhage rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181027041472N1
Registration date:2019-01-16, 1397/10/26
Registration timing:registered_while_recruiting
Last update:2019-01-16, 1397/10/26
Update count:1
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
zahra khojastehfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3872 1568
Email address
khojastehfz961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of rectal suppository of Plantago Major and Anethum Graveolens on postpartum hemorrhage rate in women at risk of bleeding
Public title
The effect of Plantago Major and Anethum Graveolens rectal suppository on postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having tendency and written consent to participate in the study.
Being Iranian and living in Mashhad
Ability to read and write
Mothers' age range between 15-50 years
tendency to normal delivery
term pregnancy
Start the active phase of labor
The score equal to or greater than 10% of prediction postpartum hemorrhage nomogram
Exclusion criteria:
medical and psychological illness
history of cesarean section or surgery on the uterus
Consumption the specific medications
severe bleeding during and after delivery
rupture grade 3 and 4
uterus and cervical rupture
using herbal or chemical drugs before or during labor
complications of childbirth in the active phase of labor
temperature more than 38 ° C during the study
rupture of embryonal membrane for more than 12 hours
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers using the spss software
Blinding (investigator's opinion)
Triple blinded
Blinding description
In intervention groups such as Plantago Major and Anethum Graveolens suppositories are apparently identical, therefore, the subjects under study and evaluators, analysts and sample allocators into two groups are blind , but in the control group only the analysts and sample allocators into three groups are blind.
Placebo
Not 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 Science
Street address
Quraishi Building, university street, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.043
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 rate
Timepoint
Before intervention; after 1st, 2nd and 4th hours after delivery
Method of measurement
Through weighing blood collection bags and disposable pads
Secondary outcomes
empty
Intervention groups
1
Description
Control group: oxytocin infusion immediately after the expulsion of placenta, according to the country's instruction.
Category
Prevention
2
Description
Intervention group 1: immediately after the expulsion of placenta and fetal membranes and uterine massage, the pregnant women will receive rectal plantago major suppository every 30 min in addition to oxytocin infusion and in order to reach the effective dose, the suppository will be used in 5 doses.
Category
Prevention
3
Description
Intervention group 2: immediately after the expulsion of placenta and fetal membranes and uterine massage, the pregnant women will receive rectal dill suppository every 30 min in addition to oxytocin infusion and in order to reach the effective dose, the suppository will be used in 5 doses.