Objectives:Find a way to faster servicl ripening.Design:interventional.Setting and conduct: The two groups were matched in the first group of sublingual misoprostol 400µg 4 hours befor procedure and the intervention group to receive cervical laminaria plus 200µg sublingual misoprostol 4 hours before procedure.Inclusion criteria: 18 to 35 years ;gestational age less than 14 weeks;closed cervix;ultrasound consecutive Blighted Ovoum or Missed Abortion or the termination of pregnancy to order a forensic document. Exclusion criteria: medical conditions such as diabetes or high blood pressure or heart disease; surgery on the cervical area of the convention; women who take certain medications or an underlying allergy;Women who have vaginal bleeding at presentation ; women with a BMI of less than 20 or more than 25 ; more than 2 previous cesarean section; uterine anomalies .intervention:Misoprostol 400µg 4 hours befor procedure in the control group and misoprostol 200µg plus laminaria in the intervention group .The outcome of the investigation's achieving the desired cervical dilation or spontaneous expulsion of pregnancy products, pain intensity during waiting period, adverse effects of the ripening methods including nausea/vomiting, diarrhea, flashing and fever, post abortive infection and finally the patients’ satisfaction at discharge
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070711020N4
Registration date:2015-07-24, 1394/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Medical Sciences, Tehran University of Medical Sciences
Expected recruitment start date
2015-07-24, 1394/05/02
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of sublingual misoprostol with sublingual misoprostol with laminaria on cervical dilation in the abortion rate from 4 to 14 weeks
Public title
Improving the effectiveness of misoprostol cervical ripening with laminaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 35 years ;gestational age less than 14 weeks;closed cervix;ultrasound consecutive Blighted Ovoum or Missed Abortion or the termination of pregnancy to order a forensic document.
Exclusion criteria: medical conditions such as diabetes or high blood pressure or heart disease; surgery on the cervical area of the convention; women who take certain medications or an underlying allergy;Women who have vaginal bleeding at presentation ; women with a BMI of less than 20 or more than 25 ; more than 2 previous cesarean section; uterine anomalies .
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods street
City
Tehran
Postal code
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
9111290040-144511
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
o04
ICD-10 code description
termination of pregnancy: legal therapeutic therapeutic abortion
Primary outcomes
1
Description
400µg sublingual misoprostol for cervical ripening
Timepoint
Every 4 hours
Method of measurement
≥Hegar7
2
Description
cervical ripening with:cervical laminaria plus 200µg sublingual misoprostol
Timepoint
Every 4 hours
Method of measurement
≥Hegar7
Secondary outcomes
1
Description
Symptoms of allergy to laminaria
Timepoint
every tow hours up to cervix prparation
Method of measurement
based on fever and Itching existance
2
Description
fever
Timepoint
every 2 hours up to preparation ofcervix
Method of measurement
Medical thermometer
Intervention groups
1
Description
Intervention group:receive cervical laminaria plus 200µg sublingual misoprostol 4 hours before procedure.
Category
Treatment - Other
2
Description
procedure Control group: sublingual misoprostol 400µg 4 hours befor procedure
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women 's Hospital
Full name of responsible person
Dr Maryam Khooshide
Street address
162 Alley, Rashid Aven,Resalat Hay wey
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr. Akbar Fotohi
Street address
Qods St, Keshavarz Blvd
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 Tehran University of Medical Sciences , Deputy of Research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Khooshide
Position
Associate professor
Other areas of specialty/work
Street address
Arash Women 's Hospital 162 Alley, Rashid Aven,Resalat Hay wey
City
Tehran
Postal code
Phone
+90 217 788 32 88
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Maryam Khooshide
Position
Associate professor
Other areas of specialty/work
Street address
Arash Women 's Hospital 162 Alley, Rashid Aven,Resalat Hay wey
City
Tehran
Postal code
Phone
+98 21 7788 3288
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nassim Yarmohammadi
Position
Gynecology Resident
Other areas of specialty/work
Street address
Arash Women 's Hospital 162 Alley, Rashid Aven,Resalat Hay wey
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)