Protocol summary

Summary
This is a prospective randomized double blinded study to compare Laminaria and misoprostol in cervical ripening for induction of labor. Study participants are 100 pregnant women, 18 to 45 years old that randomly divide into two equal groups, 1 (Misoprostol) and 2( Laminaria). Both drugs are used in patients with unfavorable cervix (0-2 centimeters dilatation and 0-30% effacement). Patients on admission, 6 hours later and then every 2 hours undergo vaginal examination. Person who will perform the first exam and use the drug is different with someone who would do next exams. Second examiner and also the patients are not aware of the type of the drug. Women With rupture of membranes, severe preeclampsia, intrauterine growth restriction and non-cephalic presentation are excluded. Misoprostol, 25 microgram suppositories, are applied intravaginally in posterior fornix. After 6 hours second dose is repeated if dilatation change does not occur. Laminaria is placed into the cervix intravaginally and it will be removed after 6 hours by first examiner and it is used also in one dose. In cases of 2-3 Centimeters dilatation, labor will be continued otherwise, oxytocin is used in both groups. Induction-to-delivery interval, fetal distress, cesarean sections rate, tick meconium and uterine hyperstimulation will be examined in both groups of the study. Finally, results will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013010712037N1
Registration date: 2013-01-23, 1391/11/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-23, 1391/11/04
Registrant information
Name
Jamileh Nezamzavareh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1445 7233
Email address
nezamzavareh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-09-15, 1391/06/25
Expected recruitment end date
2013-04-14, 1392/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
vaginal misoprostol versus laminaria for cervical ripeing in full term pregnants. A comparative randomized trial
Public title
vaginal misoprostol versus laminaria for cervical ripeing in full term pregnants. A comparative randomized trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: single pregnants with unriped cervix. Exclusion criteria: noncephalic presentation; sever preeclampsia; intrauterine growth restriction(IUGR); presence of uterine contractions; fetal distress; oligohydramnios and rupture of fetal membranes.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotb-e ravandi Blvd.
City
Kashan
Postal code
/8715988141
Approval date
2012-09-11, 1391/06/21
Ethics committee reference number
2272/1/5/29/پ

Health conditions studied

1

Description of health condition studied
vaginal delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
Dilatation of cervix
Timepoint
On admission, 6 hours later and then every 2 hours
Method of measurement
Vaginal exam based on Bishop Score

2

Description
Induction to delivery time
Timepoint
Since induction of labor to delivery
Method of measurement
Calculating time(hour)

Secondary outcomes

1

Description
Fetal distress
Timepoint
Every 15 minutes
Method of measurement
Auscultation of fetal heart

2

Description
Thick meconium
Timepoint
Time of membrane rupture
Method of measurement
Vaginal examination

Intervention groups

1

Description
Intervention Group: vaginal administration of laminaria ( one dose ) at onset of the labor induction
Category
Treatment - Drugs

2

Description
Control group: Vaginal administration of misoprostol 25 mcg (1dose) at the onset of induction of labor and if needed, the second dose administration of 25 mcg 6 hours after initial dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Shabih Khani Hospital
Full name of responsible person
Jamileh Nezam Zavareh
Street address
Shahid Beheshti street
City
Kashan

2

Recruitment center
Name of recruitment center
Kashan Beheshti Hospital
Full name of responsible person
Jamileh Nezam Zavareh
Street address
Ghotb-e ravandi Blvd.
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Jamileh Nezam Zavareh
Position
Resident of Gynecology and Obstetrics
Other areas of specialty/work
Street address
Ghotb-e ravandi Blvd.
City
Kashan
Postal code
Phone
+98 36 1445 7233
Fax
Email
fatemeh89nezam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mitra Behrashi
Position
Specialist in Gynecology and Obstetrics
Other areas of specialty/work
Street address
Ghotb-e ravandi Blvd
City
Kashan
Postal code
Phone
+98 36 1446 0180
Fax
Email
dr_behrashi2006@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Jamileh Nezam Zavareh
Position
Resident of Gynecology and Obstetrics
Other areas of specialty/work
Street address
Ghotb-e ravandi Blvd
City
Kashan
Postal code
Phone
+98 36 1445 7233
Fax
Email
fatemeh89nezam@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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