Protocol summary
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Study aim
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Comparison the effect of rectal suppository of Plantago and Anethum graveolens (Dill) on postpartum hemorrhage (PPH) rate in women at risk of bleeding
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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Postpartum hemorrhage rate
General information
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Reason for update
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Sampling and research completion dates were added
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181027041472N1
Registration date:
2019-01-16, 1397/10/26
Registration timing:
prospective
Last update:
2021-11-28, 1400/09/07
Update count:
1
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Registration date
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2019-01-16, 1397/10/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-06-22, 1398/04/01
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Actual recruitment start date
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2019-01-21, 1397/11/01
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Actual recruitment end date
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2019-03-19, 1397/12/28
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Trial completion date
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2019-03-19, 1397/12/28
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Scientific title
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Comparison of effect of rectal suppository of Plantago Major and Anethum Graveolens on postpartum hemorrhage rate in women at risk of bleeding
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Public title
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The effect of Plantago Major and Anethum Graveolens rectal suppository on postpartum hemorrhage
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 15 years old to 50 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
105
Actual sample size reached:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Table of random numbers using the spss software
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-06, 1397/07/14
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1397.043
Health conditions studied
1
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Description of health condition studied
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Postpartum hemorrhage
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ICD-10 code
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O72
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ICD-10 code description
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Postpartum hemorrhage
Primary outcomes
1
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Description
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postpartum hemorrhage rate
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Timepoint
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Before intervention; after 1st, 2nd and 4th hours after delivery
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Method of measurement
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Through weighing blood collection bags and disposable pads
Intervention groups
1
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Description
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Control group: oxytocin infusion immediately after the expulsion of placenta, according to the country's instruction.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
3
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available