Assessing the Effect of evening primrose oil on the cervical ripening in patients without a history of vaginal delivery and who are candidate for hysteroscopy compared with the control group
The goal of this study is to determineing the effect of evening primrose oil (EPO) on the dilatation & ease of cervical ripening in patients who candidate for hysteroscopy.
The study population are 25-75 years old women who present to gynecology clinic of Hazrat rasool hospital and are candidate for hysteroscopy. tThe patients are informed and assign to 2 groups randomly. iInclusion criteria includes: post- menopausal women with closed cervix <3 mm dilatation), nulliparous and premenopausal women without history of normal vaginal delivery(NVD). Exclusion criteria includes: patients with history of NVD, contraindication for use of EPO( patient with bleeding disorder or medication that slow blood clotting, patient with schizophrenia, who receives phenothiazinsphenothiazine, epilepsy) and women with structural anomally of the cervix. cCalculated sample size have 42 patients(21 patients in each group). tThe study group recieeive, two soft gels (500 mg each) of EPO vaginally in posterior fornix 6 hours before hysteroscopy and control group also receive placebo (placebo is EPO soft gels that evacuate and fill with distilledt water). All patients will be going under general anesthesia . wWe will calculate the total time to achieve10 mm dilatation of cervix with mechanical dilators and the size of first dilator that we have to insert more than medium force for each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308068588N16
Registration date:2013-11-12, 1392/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-12, 1392/08/21
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences.
Expected recruitment start date
2013-08-06, 1392/05/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effect of evening primrose oil on the cervical ripening in patients without a history of vaginal delivery and who are candidate for hysteroscopy compared with the control group
Public title
the effect of evening primrose oil on the ease of uterine endoscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: post -menopausal women with closed cervix, nulliparous and premenopausal women without history of NVD
Exclusion criteria: patients with history of NVD, contraindication for use of EPO(bleeding disorder or medication that slow blood clotting, epilepsy ,patient with schizophrenia who receives phenothiazinsphenothiazine) and women with structural anomally of the cervix :incompetent cervix , Mullerian anomally of cervix and history of cervical conization.
Age
From 25 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical sciences
Street address
Tehran University of Medical Sciences, corner of Ghods, Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2013-10-21, 1392/07/29
Ethics committee reference number
94529
Health conditions studied
1
Description of health condition studied
cervical ripening
ICD-10 code
--
ICD-10 code description
---
Primary outcomes
1
Description
Total time to get 10 millimeters diameter dilatation of cervix
Timepoint
6 hours after intervention
Method of measurement
By Chronometer
2
Description
what size of dilators need to mid forced insertion
Timepoint
6 hours after intervention
Method of measurement
By dilator
Secondary outcomes
1
Description
complication during insertion of dilators
Timepoint
afrer intervention
Method of measurement
observation
Intervention groups
1
Description
In case group, 1000 mg Evening primrose oil (two soft gels) transvaginal, 6 hours before hystroscopy
Category
Treatment - Drugs
2
Description
In case group, two soft gels of plasebo transvaginal, 6 hours before hystroscopy