Comparison of the Effect of Vaginal misoprostol with Oxytocin for the management of second trimester pregnancy terminations with IUFD in khalij fars hospital in Bandar Abbas in 2018.
The purpose of this study was to Comparison of the Effect of Vaginal misoprostol with Oxytocin for the management of second trimester pregnancy terminations with IUFD in khalij fars hospital in Bandar Abbas in 2018.
Design
They were randomly divided into two groups of 53 people. One of the groups was treated with 400 micrograms vaginal misoprostol every 6 hours for up to 48 hours and the other group was treated with high dose oxytocin 50 units in 500 cc ringer (up to a maximum dose of 300 units). In the event of failure of the treatment of the first line, the method of treatment was transferred to the groups and in case of failure of the second line (failure to pass the gestational period) the patient became a candidate for hysterotomy.
Settings and conduct
The present study is a randomized clinical trial. The population of this study was pregnant women in the second trimester of IUFD who referred to the khalij fars hospital during the year 2018.
Participants/Inclusion and exclusion criteria
Inclusion criteria were the pregnant women with 18 to 40 years of age confirmed by IUFD with gestational age of 15 to 26 weeks and exclusion criteria were multiparity more than 6, coagulopathy, multifetal pregnancy, any obstacle to induction of labor (e.g. maternal heart disease, clinical chorioamnionitis, vasa previa, placenta previa, invasive cervical carcinoma, myoma surgery or any surgery that has cut the uterine), having one or more caesarean section, and history of any uterine incision (myomectomy and etc.)
Intervention groups
One of the groups was treated with 400 micrograms vaginal misoprostol every 6 hours for up to 48 hours and the other group was treated with high dose oxytocin 50 units in 500 cc ringer (up to a maximum dose of 300 units). hysterotomy.
Main outcome variables
compare the effect of oxytocin with misoprostol on labor induction in the second trimester IUFDs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181218042033N2
Registration date:2020-02-24, 1398/12/05
Registration timing:retrospective
Last update:2020-02-24, 1398/12/05
Update count:0
Registration date
2020-02-24, 1398/12/05
Registrant information
Name
Nazanin Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
abdinazanin834@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-18, 1397/12/27
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
2019-03-18, 1397/12/27
Actual recruitment end date
2019-07-11, 1398/04/20
Trial completion date
2019-07-11, 1398/04/20
Scientific title
Comparison of the Effect of Vaginal misoprostol with Oxytocin for the management of second trimester pregnancy terminations with IUFD in khalij fars hospital in Bandar Abbas in 2018.
Public title
Comparison of the Effect of Vaginal misoprostol with Oxytocin for the management pregnancy terminations with IUFD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with 18 to 40 years of age confirmed by IUFD
gestational age of 15 to 26 weeks
Exclusion criteria:
Multiparty more than 6
Coagulopathy
Multi fetal pregnancy
Any obstacle to induction of labor (e.g. maternal heart disease, clinical chorioamnionitis, vasa previa, placenta previa, invasive cervical carcinoma, myoma surgery or any surgery that has cut the uterine)
Having one or more caesarean section
History of any uterine incision (myomectomy and etc.).
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
106
Actual sample size reached:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are no longer aware of the misoprostol or oxytosin recipes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Homozgan University of medical sciences
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.HUMS.198.001
Health conditions studied
1
Description of health condition studied
Intrauterine fetal death
ICD-10 code
O04
ICD-10 code description
Complications following (induced) termination of pregnancy
Primary outcomes
1
Description
Induction- to-delivery interval time
Timepoint
6-48 hours after misoprostol and oxytocin administration
Method of measurement
clock
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vaginal misoprostol: 400 μg every 6 hours up to 48 hours
Category
Treatment - Drugs
2
Description
Control group: Oxytocin at a dose of 50 units of oxytocin at 500 cc Ringer (up to a maximum dose of 300 units)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hormozgan University of Medical Sciences
Full name of responsible person
Naznin Abdi
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas
City
Bandar abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 71 3647 9830
Email
abdinazanin834@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abdolazim Nejati Zadeh
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3647 9830
Email
azimnejate@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Atena Gisooee
Position
Resedient
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3647 9830
Email
gisooeeatena@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Bandare-abbas University of Medical Sciences
Position
Nazanin Abdi
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 736479830
Email
abdinazanin834@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nazanin Abdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hormozgan University Of Medical Sciences, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 36479830
Email
nazanin.abdi57@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2018 Ethic form: 2018
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Hormozgan university of medical sciences Ethic form: OB & Gyn ward Hormozgan university of medical sciences
What processes are involved for a request to access data/document