Termination of second trimester of pregnancy is carried out with medical and surgical methods. In these methods, misoprostol is noticed due to cheap cost and stability at room temperature. The aim of this study is comparing vaginal versus oral misoprostol for second–trimester pregnancy termination. In this study 40 women with inclusion criteria (14-24 weeks of gestation singletion) that their pregnancy should be terminated due to maternal or fetal cause and exclusion criteria (Multiple pregnancy, Chorioamnionits, pervious uterus incision, parity over 3, patients with asthma , liver, kidney and heart disease) enter to study. The patients will be randomize in two groups, and they will be matched using maternal age and parity. At first, all of patients receive 600 µg vaginal Misoprostol and then they will be randomized to receive either oral or vaginal misoprostol 400 mg every 4 hours for a maximum of 3 doses. Finally, efficacy of treatment (rate of termination) and complication (sever vaginal bleeding, fever and curretage) will be compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103281760N11
Registration date:2011-11-01, 1390/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-01, 1390/08/10
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2010-03-16, 1388/12/25
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vaginal versus oral Misoprostol for second–trimester pregnancy termination
Public title
Vaginal versus oral Misoprostol for second–trimester pregnancy termination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women Hospitalized in the second–trimester (24-14 weeks gestation) for abortion with single pregnancy, parity conditions 1 to 3, without pain, uterine infection and dilatation are less than 2cm. Exclusion criteria: Multiple pregnancy, Chorioamnionits previous uterus incision, parity over 3, patients with asthma, liver, kidney and heart disease.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
30/165/ژ/پ
Health conditions studied
1
Description of health condition studied
Second trimester termination of pregnancy
ICD-10 code
P96.4
ICD-10 code description
Termination of pregnancy, fetus and newborn
Primary outcomes
1
Description
abortion
Timepoint
The start of the intervention up to 24 hours
Method of measurement
Clinical examinations
Secondary outcomes
1
Description
Number of tablets consumed
Timepoint
The start of the intervention up to 24 hours
Method of measurement
Clinical examinations
2
Description
Possible Complications
Timepoint
The start of the intervention up to 24 hours
Method of measurement
Clinical examinations
3
Description
Amount of bleeding
Timepoint
The start of the intervention up to 24 hours
Method of measurement
Clinical examinations
4
Description
The need for curettage
Timepoint
The start of the intervention up to 24 hours
Method of measurement
Clinical examinations
Intervention groups
1
Description
First group: 600 µcg vaginal Misoprostol as initial dose, and then 400 micrograms of oral misoprostol every four hours up to receive three doses.
Category
Treatment - Drugs
2
Description
Second group: 600 µcg vaginal Misoprostol as initial dose, and then 400 micrograms of vaginal misoprostol every four hours up to receive three doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Masoumeh Enayati
Street address
Ayatollah Rouhani Hospital, Gangafroz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
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 and Technology
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
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com, zahra@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Ayatollah Rouhani Educational Center
Full name of responsible person
Dr. Shahla Yazdani
Position
Gynecologist
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Ayatollah Rouhani Educational Center
City
Babol
Postal code
Phone
+98 11 1223 8301
Fax
Email
Shahla_yazdani_1348@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)