Assessing the effect of supplemental injectable progesterone on complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS
Assessing the effect of supplemental injectible progesterone on complicated monochorionic diamnionic twin pregnancies radiofreuncy ablated with cervical length of 25 mm in TVS
This study performed at Yas women hospital
patients in the intervention group were pregnancies who underwent RFA for one of the twins and had a cervical length longerer than 25mm who were administered 17-hydroxyprogesterone caproate
control group were complicated twin pregnancies undergone RFA
for randomization equal to the number of patients a & b letters were put in a pocket and before each RFA procedure a letter has been drawn to determine allocation of the patient in case versus control group
the data analyzer was blinded to group allocations
Participants/Inclusion and exclusion criteria
complicated monochorionic diamnionic twin pregnancies radiofreuncy ablated with cervical length of 25 mm in TVS
exclusion criteria : history of cervical insufficiency or recurrent pregnancy loss of second trimester
history of preterm delivery in previous pregnancies
cerclage
twin-twin transfusion syndrome
Intervention groups
complicated monochorionic diamnionic twin pregnancies radiofreuncy ablated with cervical length of 25 mm in TVS
patients in the intervention group were administered a dose of 17 hydroxyprogesterone caproate 250mg intramuscular and the same dose was prescribed weekly until 36 weeks gestation
for control group, patients underwent radiofrequency ablation and no further drug intervention was done
Main outcome variables
Duration of pregnancy;
preterm premature rupture of membranes;
neonate admission to NICU.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046496N1
Registration date:2020-03-24, 1399/01/05
Registration timing:retrospective
Last update:2020-03-24, 1399/01/05
Update count:0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Forough Jabbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 7182
Email address
f-jabbari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-17, 1397/12/26
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of supplemental injectable progesterone on complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS
Public title
Assessing the effect of supplemental injectable progesterone on complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS
intrauterine growth restriction or anomaly of one of the twins
Exclusion criteria:
personal history of cervical insufficiency or second trimester recurrent pregnancy loos
history of preterm delivery in previous pregnancies
cerclage
twin-twin transfusion syndrome (TTTS)
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
To the number of samples in each group, letters A or B were written on cards and put in a pocket. Prior to each intervention a card was taken out determining the patient allocation to case or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Follow up and result assessment of patients were performed by health care providers who were blind to allocation and the final results were available to the researcher and data analyzer by codes A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran national committee of ethics in biomedical research
Intervention group: monochorionic twin pregnancies complicated with anomalous fetus or selective IUGR of a co-twin with cervical length more than 25 millimeters undergoing radiofrequency ablation, supplemental injectable progesterone in the form of 17hydroxyprogesterone caproate will be administered intramuscularly and the same dose will be injected weekly until 36 weeks gestation. the patients will be compared to the control group for whom , only the RFA is done and no further drug administration is performed.
Category
Treatment - Drugs
2
Description
Category
empty
3
Description
Control group: monochorionic complicated twin pregnancies by anomalous fetus or selective IUGR and a cervical length more than 25mm, undergo ablation of the abnormal co-twin with radiofrequency and no supplemental progesterone and pregnancy outcome is followed.RFA is a single session procedure done through a needle using radiofrequency waves, resulting in occlusion of the abnormal co-twin cord and intrauterine fetal death while the other continue to grow.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Women Hospital
Full name of responsible person
Forough-o-Zaman Jabbari
Street address
Karim Khan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Email
forouq.jabbari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Forough-o-Zaman Jabbari
Street address
Karimkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Email
forouq.jabbari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fough-o-Zaman Jabbari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karimkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Email
forouq.jabbari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi Sharbaaf
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 912 113 4105
Email
rahimish@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Forough-o-Zaman
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 937 253 3390
Email
forouq.jabbari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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