Protocol summary

Study aim
Determining the frequency of normal delivery after using three groups of evening primrose, mechanical and misoprostol in 41-week pregnant women hospitalized in Fatemieh Hospital in 1401
Design
A clinical trial of three groups, with parallel groups, randomized by random block allocation method, phase 3 on 420 pregnant women of 41 weeks.
Settings and conduct
Informed consent will be obtained from patients. After entering the delivery room, the patients undergo a vaginal examination and Bishop's score is calculated and then they are included in one of the three groups randomly. In the evening primrose group, one 1000 mg evening primrose capsule from Dana Pharmaceutical Company is prescribed vaginally every hour. Evening primrose is used until the beginning of the active phase of labor (exam 3-4 cm). In the mechanical group, using the Extra amnionic saline infusion method, a cervical Foley catheter is inserted and 30 cc of normal saline is injected per hour, and after inserting the balloon, the balloon is allowed to come out for a maximum of 12 hours. Then, in the third group of patients, misoprostol suppository 25 are placed vaginally. Bishop's score is determined every two hours in all three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women at 41 weeks are candidates for termination of pregnancy by natural delivery Exclusion Criteria: Patients with active labor phase Patients with spontaneous onset of pain Not having an emergency delivery indication
Intervention groups
The effect of three methods (evening flower, mechanical method and misoprostol) in the delivery process of primiparous pregnant mothers is investigated. Pregnant mothers are randomly divided into 3 groups.
Main outcome variables
Comparison of natural birth process, labor duration, side effects and condition of the baby in three groups of evening primrose, mechanical and misoprostol.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230522058253N1
Registration date: 2023-06-16, 1402/03/26
Registration timing: prospective

Last update: 2023-06-16, 1402/03/26
Update count: 0
Registration date
2023-06-16, 1402/03/26
Registrant information
Name
neda alimohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0808
Email address
nalimohamadi68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of frequency of Natural vaginal delivery after preparation of cervix with evening primrose, EASI mechanical method and misoprostol in 41 week pregnant women
Public title
A comparative study of the effect of evening primrose, EASI mechanical method and misoprostol in Natural Vaginal Delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women at 41 weeks are candidates for termination of pregnancy by natural delivery method
Exclusion criteria:
Pregnant women with IUFD, SGA, IUGR Pregnant women with spotting and abnormal placenta
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 420
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be consulted upon entering the hospital and informed consent will be obtained from the patient. After entering the delivery room, they undergo a vaginal examination and Bishop's score is calculated, and then they are included in one of the three groups randomly. Randomization is done by writing the letters A, B and C on three sheets and putting them in a box, and one of these sheets is taken out by the researcher for each patient. After completion, again for the next three patients, sheets will be removed with this random method until we reach the desired sample size.
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 hamadan University of Medical Sciences
Street address
Fatemieh hospital, Pastaran Ave.
City
hamadan
Province
Hamadan
Postal code
6517789971
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.UMSHA.REC.1401.942

Health conditions studied

1

Description of health condition studied
Comparison of frequency of Natural vaginal delivery after preparation of cervix with evening primrose, EASI mechanical method and misoprostol in 41 wee
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bishop's scoring system
Timepoint
Two hours after using misoprostol and the EASI mechanical method and evening primrose
Method of measurement
Bishop's scoring system to check cervix inducibility

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: in the evening primrose group, one 1000 mg evening primrose capsule from Dana Pharmaceutical Company is prescribed vaginally every hour. Evening primrose is used until the beginning of the active phase of labor (exam 3-4 cm).
Category
Treatment - Drugs

2

Description
Intervention group2: In the mechanical group, using the Extra amnionic saline infusion method, a Foley cervical catheter is inserted and 30 cc of normal saline is injected per hour, and after the balloon is inserted, the balloon is allowed to come out for a maximum of 12 hours.
Category
Treatment - Devices

3

Description
Intervention group3: Misoprostol suppository 25 micrograms is placed vaginally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Sima Kamkar
Street address
Pastaran Ave
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3828 3939
Email
nalimohamadi68@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokuhi
Street address
Pastaran Ave, Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3828 3939
Email
nalimohamadi68@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sima Kamkar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pastaran Ave
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3828 3939
Email
sima_kamkari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sima Kamkar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pastaran Ave
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3828 3939
Email
sima_kamkari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Neda Alimohammadi
Position
Nurse-Nicu
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pastaran Ave- Fatemieh Hospital
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3838 0808
Fax
Email
nalimohamadi68@yahoo.com

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
Not applicable
Data Dictionary
Not applicable
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