Clinical trial of the efficacy of misoprostol with folley catheter (traction) and rising induction in second trimester termination in Fatemieh Hospital, Hamedan
In this randomized clinical trial we will recruit the pregnant women in second trimester who will be admitted for termination of pregnancy due to medical indications. The patients will be randomly assigned in two groups of traction and rising induction & misoprostol. The main study goal is to compare these two groups from the aspect of time of delivery, need to curettage and side-effects in each groups. Before starting the research, we will talk to women about each methods and their possible side-effects for signing the informed consent. The outcomes will be compared in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103146066N1
Registration date:2011-10-13, 1390/07/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-13, 1390/07/21
Registrant information
Name
Maryam Habibi Kiasaraee
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7082
Email address
m.habibikia@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2011-02-25, 1389/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the efficacy of misoprostol with folley catheter (traction) and rising induction in second trimester termination in Fatemieh Hospital, Hamedan
Public title
The effect of misoprostol with folley catheter (traction) & Rising induction in second trimester termination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women admitted for trmination of pregnancy in second trimester with medical indications and don`t have any contraindication for study intervention; such as heart failure, severe anemia, using high dose corticosteroids and history of adrenal failure or allergic reaction
Exclusion criteria:
All women are not in mid-trimester and they do not accept to participate in the study
Age
From 14 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Fahmideh boulvar, Hamedan
City
Hamedan
Postal code
Approval date
2009-07-21, 1388/04/30
Ethics committee reference number
58470/7/70/16/پ
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Time from beginig the induction to delivery
Timepoint
Time of beginig the induction till 48 hours
Method of measurement
Hour
2
Description
Need for curettage
Timepoint
30 minute till one hour after delivery
Method of measurement
Standard teatment protocol
Secondary outcomes
1
Description
The days of admission in hospital
Timepoint
Study period
Method of measurement
Medical documents reports
2
Description
Possible side-effect
Timepoint
Study period
Method of measurement
Medical documents reports
Intervention groups
1
Description
Intervention group: A 16-foley catheter will be put in the cervix, until upper end of it in the internal os; then its collecting bag will be filled with saline and then we will pull the catheter down. In that time we will administer 2gr ampicillin intravenously for prophylaxy three times a day. Then we will do rising induction simultaneously. 50Uoxytocin in 500cc ringer or ringer lactate solution will be administered in 3 hours then dieresis will be induced for an hour with D5W %( 500cc). Maximum dose of oxytocin is 300u.
Category
Treatment - Other
2
Description
In control group: misoprostol (200microgram) vaginal suppository will be administered until 1400 microgram per day for achieving treatment effect or presence of side-effects
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh obstetrics & gynecology center, Hamedan
Full name of responsible person
Dr.Shohreh Alimohammadi
Street address
Fatemieh obstetrics & gynecology center
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Ghaleiha
Street address
Hamedan University of Medical Sciences, Fahmideh boulvar, Hamedan
City
Hamedan
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, Hamedan 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
Hamedan University od Medical Sciences
Full name of responsible person
Dr. Shohreh Alimohammadi
Position
Perinatalogist
Other areas of specialty/work
Street address
Hamedan University od Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1827 7013
Fax
Email
m.habibikia@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh hospital
Full name of responsible person
Dr. Shohreh Alimohammadi
Position
Perinatalogist
Other areas of specialty/work
Street address
Hamedan University od Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1827 7013
Fax
Email
m.habibikia@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University od Medical Sciences
Full name of responsible person
Maryam Habibi Kiasaraee
Position
Obstetrics & gynecology assistance
Other areas of specialty/work
Street address
Fatemieh obstet & gynecologic center
City
Hamedan
Postal code
Phone
+98 988118277013
Fax
Email
m.habibikia@gmail.com; m.habibikia@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)