Objectives: The aim of this study is to determine the effect of oral Evening Primrose Oil on cervical ripening and pregnancy outcomes on nulliparous women.
Study population: Healthy women with low-risk pregnancy and gestational age (40 weeks) (40 weeks + 6days) for prenatal care refer to the prenatal clinic in shahid Akbar Abadi Hospital in 1394.
Study groups : Two groups including drug (oral capsule 1000 mg of Evening Primrose Oil) and placebo( oral capsules 50 mg of gelatin).
Sample size: 80 persons
Blinding and randomization: This study will be accomplished randomized Triple-blind clinical trial.
Trial phase: In this study does not apply
Setting and conduct: At first for each of women with low risk pregnancy; gestational age 40 weeks to (40 weeks + 6days) based on LMP or ultrasound in first trimester of pregnancy; cervical bishop score less than 4; normal BPP and NST, the demographic questionnaire accompanying with initial examinations, including the mother's vital signs, the fetal heart rate, uterine contractions and cervical Bishop score will be completed. Exclusion criteria are mothers who consume them is less than two capsule per day; appears possible side effects of drugs such as headache; nausea; diarrhea and etc.Then each of the participants takes a bottle containing 14 oral capsule 1000 mg of Evening Primrose Oil (2 capsules every 12 hours daily for a weak) or placebo containing 14 oral capsules 50 mg, including gelatin in identical bottles. After the capsules are taken or if because of alarming symptoms like leakage; bleeding; decreased fetal movement; severe abdominal pain the patient goes to hospital, Researcher will go to beside of mothers and record complete information and examination in questionnaire. When mother go to delivery room, vaginal to calculate the Bishop score will record and draw partograph. Main outcome measures including Primary : Ripening Of cervix, secondary: during of labor stages; during of active phase; Type of delivery; apgar score in first and fifth minutes of born and neonatal transport to NICU; Induction and The duration of using oxytocin till the active phase the two groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507022248N17
Registration date:2015-08-19, 1394/05/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Science+Vice Chancellor for research of the international branch of Iran University of Medical Science
Expected recruitment start date
2015-07-27, 1394/05/05
Expected recruitment end date
2015-11-26, 1394/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Evening Primrose Oil on cervical ripening and pregnancy outcomes in nulliparous women
Public title
Effect of Evening Primrose Oil on cervical ripening and pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: cephalic presentation; alive fetus; with gestational age 40 weeks to (40 weeks + 6 days) based on LMP or ultrasound in first trimester; Normal patterns of fetal heart rate; Without uterine contractions; cervical bishop score less than 4 intact membranous; Maternal height more than 150 cm; non-addicted persons; normal adjusted BPP at the time of inclusion;An ultrasound of the placental grading;weight of fetus between 2500-4000 grams based on physical examination or ultrasonography; Low-risk pregnancy ( have no known surgical and internal disease or pregnancy complication such as previa, abruption, preeclampsia , no known fetal problems;Avoiding the enema, Intercourse, laxatives, the use of herbal medicines, chemical or traditional methods for induction of labor; Lack of vaginal examination 24 hours before the begining till end of the study; Exclusion criterias: appears possible side effects of drugs such as headache, nausea, diarrhea and etc, those who consume them is less than two capsule per day, withdrew from the partnership at any stage of the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
People will be allocated randomly in one of two groups primrose capsules and placebo.At first, the names of each of the two groups are written on paper and placed in a separate envelope. The first will be removed one of the envelopes the next person will be in the other group and again, the third will be removed one of the envelopes the next person will be in the other group. In this way people will be located in one of two groups until the completion of the sample size .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences
Street address
Hemmat freeway (beside Milad Tower), Tehran
City
Tehran
Postal code
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
IR.IUMS.REC.1394. 26090
Health conditions studied
1
Description of health condition studied
Ripening of cervix
ICD-10 code
O60-O75
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
Ripening Of cervix
Timepoint
During the first week of intervention and labor
Method of measurement
bishop score Table
Secondary outcomes
1
Description
duration of first، second and third stages of labor
Timepoint
During the first week of intervention and labor
Method of measurement
chronometer/Examination /check list/observation
2
Description
Type of delivery
Timepoint
During the first week of intervention and labor
Method of measurement
End of study/observation
3
Description
infant apgar score
Timepoint
first and fifth minute after delivery
Method of measurement
7 and more, under 7(According to Apgar table)
4
Description
neonatal transport to NICU
Timepoint
During the first 24 hours after childbirth
Method of measurement
check list
5
Description
Induction
Timepoint
During the labor
Method of measurement
check list/observation
6
Description
The duration of using oxytocin in the active phase
Timepoint
During labor
Method of measurement
chronometer/check list/observation
Intervention groups
1
Description
Oral Evening primrose capsules, from (40 weeks) to ( 40 +6 weeks) , 2 capsules of1000 mg every 12 hours daily for a week ( Manufacturing by Traditional Medicine Research Center Shahed University)
Category
Treatment - Drugs
2
Description
Placebo capsule containing gelatin, 50 mg, 2 capsules every 12 hours daily for a week ( Manufacturing by Traditional Medicine Research Center Shahed University)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
mahnaz kalati
Street address
Molavi Street, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of the international branch of Iran University of Medical science
Full name of responsible person
Dr.mohamad sadegh ghasemi
Street address
Hemmat freeway (beside Milad Tower), Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of the international branch of Iran University of Medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
The international branch of Iran University of Medical Sciences and Heath
Full name of responsible person
mahnaz kalati
Position
Student of MSc, mail partner of research
Other areas of specialty/work
Street address
Tehran, shahid Hemmat Highway (next to Milad Tower)
City
Tehran
Postal code
Phone
+98 21 8670 2031
Fax
Email
mahnazkalati77@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fereshte Jahdi
Position
master of scince in midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
jahdi.fr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The international branch of Iran University ofMedical Sciences and Heath
Full name of responsible person
mahnaz kalati
Position
Student of MSc, mail partner of research
Other areas of specialty/work
Street address
Tehran, shahid Hemmat Highway (next to Milad Tower)
City
Tehran
Postal code
Phone
+98 21 8670 2031
Fax
Email
mahnazlalati77@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)