1. Home
  2. Approved trials
  3. » فارسی

Comparison of effects of vaginal misoprostol tablet with vaginal evening primrose capsule on ripening of the cervix in nulliparous women

Protocol summary

Study aim
Determine and compare the effect of vaginal misoprostol tablet with vaginal evening primrose capsule on ripening of the cervix Determine and compare the effect of vaginal misoprostol tablet with vaginal evening primrose capsule on bishop score before and after intervention
Design
The aim of this study is to determine and compare the effect of vaginal misoprostol tablet with vaginal evening primrose capsule on ripening of the cervix as a single-blind randomized clinical trial on 90 primiparous women with gestational age of 40 weeks (45 patients in the misoprostol group and 45 in the Gorgan group) which will have the following conditions: First pregnancy, gestational age 40 weeks based on the first day of the last menstruation or first trimester ultrasound, Bisap score less than 4, normal biophysical and non-stress test. Mothers, who have potential drug-related complications and problems such as Lack of Fetal Movement and bleeding, will be excluded. Study phase: not applicable. The simple random method is used.
Settings and conduct
The misoprostol group will be given the vaginal misoprostol tablet that will be supervised and ordered by a gynecologist in hospital based on a 25-microgram (one-eighth vaginal tablet 200 micrograms) dose from the 40th week of pregnancy. The evening primrose group will use a 1000 mg capsule of evening primrose vaginal from 40 weeks of gestation daily for one week, which will be placed by the researcher in their cervix, and each day be referred to a researcher in the clinic to place the capsule. The training will be given on how to count the movements of the fetus and the symptoms of the onset of labor. the daily registration form will be provided to the units. Both groups will be followed by researcher from time of admission and the results of the examinations will be recorded in the form. Maternity ward of Pasteur Hospital and selected clinic affiliated to Bam University of Medical Sciences
Participants/Inclusion and exclusion criteria
First pregnancy, gestational age 40 weeks based on the first day of the last menstruation or first trimester ultrasound, Bisap score less than 4, normal biophysical and non-stress test. Mothers, who have potential drug-related complications and problems such as Lack of Fetal Movement and bleeding, will be excluded.
Intervention groups
The misoprostol group will get the vaginal misoprostol tablet which be supervised and ordered by a gynecologist in hospital based on a 25-microgram (one eighth vaginal tablet 200 micrograms) dose from the 40th week of pregnancy The evening primrose group, 1000 mg capsule of evening primrose Vaginal, from the 40th week of gestation, is given one day per day for one week and Placed by the researcher in their cervix.
Main outcome variables
Ripening of the cervix

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180101038176N1
Registration date: 2018-03-03, 1396/12/12
Registration timing: prospective

Last update: 2018-03-03, 1396/12/12
Update count: 0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Narges Mirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4431 2232
Email address
nargesmirzade@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-12, 1396/12/21
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of vaginal misoprostol tablet with vaginal evening primrose capsule on ripening of the cervix in nulliparous women
Public title
Comparison of effects of misoprostol with evening primrose on ripening of the cervix in nulliparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-35 years old First pregnancy Singleton pregnancy Presentation of fetal cephalic Live fatal Gestational age 40 weeks based on the first day of the last menstruation and first trimester Medical ultrasound Natural pattern of fetal heartbeat No uterine contractions Bishop score less than 4 Healthy amniotic bag Mother's height is more than 150 cm BMI less than 30 Not having drug abuse Natural biophysical profiling test at the time of starting the study Having an ultrasound for pair grading (zero and one Grade) Estimated fetal weighing 2500-4000 gr based on manual examination of the abdomen or ultrasound Low risk pregnancy (Not suffering from known internal and surgical diseases and complications of pregnancy such as previa, abruption, preeclampsia, and the absence of known fetal problems) No vaginal examination a 24 hours before starting the study Avoid doing enema, sexual intercourse, laxative, herbal medicines including castor oil and homeopathic remedies, chemotherapy, breast stimulation and traditional methods of initiating Birth pain 24 hours before the start of study until the end
Exclusion criteria:
Any problems that require emergency action, such as not moving the fetus, mother's bleeding Get any herbal medicine during the study period Intercourse during the study possible side effects of the drug Cancellation of participation in the study at each stage
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The study units is divided into two groups by simple random method in two groups: misoprostol and evening primrose. a 90- pocket box is placed , each of the pockets is assigned to one of the two groups of misoprostol and evening primrose by random number table. The first person removes the pocket number 1, and next members will remove the pockets in their order numbers and assign them to the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Eligible participants are kept blind to being assigned to dedicate study groups. It is explained to those who are in one of the two groups of misoprostol and evening primrose, but they do not know which group they are.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St., Shahid Chamran Highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.SBMU.PHNM.1396.851

Health conditions studied

1

Description of health condition studied
ripening of the cervix
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Ripening of the cervix
Timepoint
since the onset of intervention and labor
Method of measurement
Bishop's Scoreboard

Secondary outcomes

empty

Intervention groups

1

Description
The evening primrose group, 1000 mg capsule of evening primrose Vaginal, from the 40th week of gestation, is given one day per day for one week and Placed by the researcher in their cervix.
Category
Treatment - Drugs

2

Description
Control group:The misoprostol group will be given the vaginal misoprostol tablet that will be supervised and ordered by a gynecologist in hospital based on a 25-microgram (one-eighth vaginal tablet 200 micrograms) dose from the 40th week of pregnancy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternity ward of Pasteur hospital and selected clinic affiliated to Bam university of medical scien
Full name of responsible person
Narges Mirzade
Street address
No. 12, Shahid Motahari Ave.,
City
Bam
Province
Kerman
Postal code
7661716381
Phone
+98 34 4431 2232
Email
nargesmirzade@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Rezghi
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St,. Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Mirzade
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
nargesmirzade@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Sheikhan
Position
Educator
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 34 4431 2232
Email
zsheikhan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Mirzade
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 34 4431 2232
Email
nargesmirzade@sbmu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...