Comparision of the Effect of Vaginal Capsule of Evening Primrose Oil and Misoprostol on Cervical Ripening of Nulliparous Women with Post-term Pregnancy
Comparision of the Effect of Vaginal Capsule of Evening Primrose Oil and Misoprostol on Cervical Ripening of Nulliparous Women with Post-term Pregnancy
Design
This study is a clinical trial with random allocation، Samples will be divided in two groups: Intervention, Control. Research community: Women with post term pregnancy admitting to maternity ward of Besat Hospital in Sanandaj in 2018. The sample size is 130 patients
Settings and conduct
Location: Sanandaj Besat Hospital، Single-blind clinical trial. Participation are unaware about intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy nulliparous women, Lack of contraindications for the use of evening primrose oil and misoprostol, Gestational age upper 40 weeks and 6 days, Single pregnancy and Live fetus, Cephalic presentation, Fetal heart rate pattern is normal، Absence of uterine contractions, Bishop Score lower than or equal to 4
Intervention groups
In the intervention group 500 mg capsule of evening primrose oil will implanted vaginally into posterior fornix and 25 micrograms of misoprostol to be given to the mother sublingually . In the control group 25 micrograms of misoprostol sublingually will be given and an empty capsule (placebo) will be placed vaginally in the posterior fornix. After 6 hours the Bishop scores will be
evaluated and recorded. If there is necessary 2 doses will be repeated.
Main outcome variables
Effacement، Dillatation and Consistancy of Cervix، Bishope score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180224038846N1
Registration date:2019-02-22, 1397/12/03
Registration timing:prospective
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Soma Bahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3377 3306
Email address
Bahmani.S@muk.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2639-06-22, 2018/04/01
Expected recruitment end date
2639-09-21, 2018/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the Effect of Vaginal Capsule of Evening Primrose Oil and Misoprostol on Cervical Ripening of Nulliparous Women with Post-term Pregnancy
Public title
Comparision of the Effect of Vaginal Capsule of Evening Primrose Oil and Misoprostol on Cervical Ripening of Nulliparous Women with Post-term Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Healthy nulliparous women
Lack of contraindications for the use of evening primrose oil
Lack of contraindications for the use of misoprostol
40 weeks and 6 days of gestational age based on the date of the first day of the last menstruation or the first trimester ultrasonography
Single pregnancy and live fetus
Cephalic presentation
Fetal heart rate pattern is normal
Absence of uterine contractions
Bishop score lower than or equal to 4
Intact membranes
Exclusion criteria:
Gestational age below 40 week and 6 days
NST nonreactive
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to treatment with the toss of a coin
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single blinded.The study consisted of two groups of intervention (Capsule of evening primrose oil and misoprostol) and The control group (Capsule of placebo and misoprostol) and Participants in this study will receive treatment that would be totally unaware.
Placebo
Used
Assignment
Parallel
Other design features
According to the searches made, No study has been conducted on the effect of evening primrose oil capsules on cervical ripening in post-term women in Sanandaj city and This research will be conducted for the first time in Sanandaj.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdestan University of Medical Sciences- Pasdaran Street -Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
ir.muk.rec.1396/367
Health conditions studied
1
Description of health condition studied
Post Term Pregnancy
ICD-10 code
O48.0
ICD-10 code description
Post-term pregnancy
Primary outcomes
1
Description
Cervical ripening rate
Timepoint
Every 6 hours as needed up to 3 doses
Method of measurement
In this study, cervical ripening was evaluated based on the evaluation of 5 components (dilatation, effacement, condition and strength and display station of the organ). Bishop score higher than 9 show the highest level of cervical preparation and lower than 4 suggest undesirable cervical status.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The nulliparous women with post-term pregnancy admitted to maternity ward of Besat hospital with less than 4 Bishop score will be the interventional group. For this group evening primrose oil as a gelatin capsule (500 mg) vaginally will be inserted into posterior fornix and misoprostol 25 micrograms sublingually will be received.
Category
N/A
2
Description
Control group: The nulliparous women with post term pregnancy admitted to maternity ward of Besat hospital with less than 4 Bishop score will be control group. For this group placebo capsule vaginally will be inserted into posterior fornix and 25 micrograms misoprostol sublingually will be received.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital of Sanandaj-Kurdistan University of medical Sciences