A comparative study on the effect of vaginal misoprostol usage with the combination of evening primrose and vaginal misoprostol in the treatment of missed abortion.
A comparative study on the effect of vaginal misoprostol usage with the combination of evening primrose and vaginal misoprostol in the treatment of missed abortion.
Design
140 Pregnant women with missed abortion in intervention and control groups, Clinical trial ,Randomized, It is not possible to be blind
Settings and conduct
The study population was all pregnant women referred to Niknafs Rafsanjan Hospital and under 20 weeks of gestation with the diagnosis of missed abortion and is randomly assigned to one of 2 intervention or control groups.The sample size was estimated based on statistical calculations of 140 people (70 in each group).The intervention group is recommended to use two vaginal primerose capsules of 1000 mg at bedtime. As placebo is not effective in controlling cervical readiness, there is no need for placebo. After referral, the next morning, misoprostol is vaginally implanted and hospitalized by the emergency midwife. After studying the case file, the researcher extracts the necessary information from the file and enters the checklist.
Participants/Inclusion and exclusion criteria
The inclusion criteria: All of women with a diagnosis of missed abortion;inclination to participate in the study; selection of Niknafs hospital for abortion induction.The exclusion criteria:vaginal bleeding; diseases associated with disorders Hemorrhagic agents,anticoagulant drugs, patients with history of psychiatric disorders in the phenothiazine category,and epilepsy patients
Intervention groups
Intervention group: The vaginal usage of two1000mg Primrose capsules at the night before hospitalization.Control group:No placebo prescription needed.
Main outcome variables
Dosage of Misoprostol, Disposal time of pregnancy products, Severity of the bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026971N8
Registration date:2020-02-15, 1398/11/26
Registration timing:registered_while_recruiting
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-12, 1398/08/21
Expected recruitment end date
2020-11-11, 1399/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of vaginal misoprostol usage with the combination of evening primrose and vaginal misoprostol in the treatment of missed abortion.
Public title
The effect of evening primrose in the treatment of missed abortion process.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of women with a diagnosis of missed abortion
Inclination to participate in the study
Selection of Niknafs hospital for abortion induction
Exclusion criteria:
Vaginal bleeding
diseases associated with disorders Hemorrhagic agents, anticoagulant drugs, Patients with history of psychiatric disorders in the phenothiazine category, and epilepsy patients
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization method is assigned to intervention group 1 and control group 2 and the cards with numbers 1 and 2 are written. Study subjects remove one of these cards and fall into one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Science
Street address
Central department of Rafsanjan University Medical Science،immam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.RUMS.REC.1398.146
Health conditions studied
1
Description of health condition studied
Missed abortion
ICD-10 code
O02.1
ICD-10 code description
Missed abortion
Primary outcomes
1
Description
Dosage of misoprostol
Timepoint
After the abortion is complete
Method of measurement
Information recorded in the file
2
Description
Disposal time of pregnancy products
Timepoint
After the abortion is complete
Method of measurement
Information recorded in the file
3
Description
The severity of the bleeding
Timepoint
After the abortion is complete
Method of measurement
Information recorded in the file
Secondary outcomes
1
Description
Pain rate
Timepoint
During of the hospitalization
Method of measurement
Visual analogue scale
2
Description
Number of days of hospitalization
Timepoint
After the patient is discharged
Method of measurement
The information recorded in the file
3
Description
Curettage
Timepoint
During of the hospitalization
Method of measurement
The information recorded in the file
Intervention groups
1
Description
Intervention group: In addition to routine treatment of missed abortion with vaginal misoprostol, Two 1000 mg primerose capsules made by Barij essential company,10 pm before hospitalization,Vaginal
Category
Treatment - Drugs
2
Description
Control group: Routine treatment of missed abortion with vaginal misoprostol
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
NickNaf maternity hospital Rafsanjan
Full name of responsible person
Mozhgan Mahmoodi Nasab
Street address
Shohada Ave.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 9040
Email
info@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsizadeh
Street address
Imam Ali Blvd., Dept. of Research & Technology,Central Office of Rafsanjan University of Medical Sciences,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Web page address
http://vcrt.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD