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Comparative assessment of ring pessary and cervical cerclage for preterm birth in twin pregnancies

Protocol summary

Study aim
Since there is no available previous study on the preference of cerclage or pessary to prevent preterm delivery in twin pregnancies, this study aims to do comparative assessment of the prevalence of preterm delivery in twin pregnancy using these two methods.
Design
This phase 3 clinical trial study was performed on 50 twin pregnant women referring to Tehran Taleghani hospital trough years from 2017 to 2019 with cervical length less than 25 mm, which are assigned randomly to two groups of 25, using cerclage (control) and pessary (intervention), and the ratio of the incidence of preterm delivery in both groups is examined and compared
Settings and conduct
We will conduct a randomized trial comparing pessary placement with cerclage in women who have twin pregnancy and have a cervical length of 25 mm or less at 14 weeks to 24 weeks and 6 days of gestataion. Both groups will receive treatment with vaginal progestrone. The study will be carried out in Taleghani Hospital, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Twin pregnant women referring to Tehran Taleghani hospital from 2017 to 2019 with cervical length less than 25 mm in the 14th week after measurement by TVS. Its noteworthy to say that all women will receive proluton. exclusion criteria: Women with high parity, uterine anomalies, chronic diseases such as rheumatoid diseases, kidney failure, diabetes, recurrent abortion, women over 40 and under 18 years old, history of preterm delivery, history of previous serology, neonatal death and painful uterine contractions.
Intervention groups
pessary placement vs. cerclage in women who had twin pregnancy and had a cervical length of 30 mm or less at 14 weeks to 24 weeks and 6 days of gestataion
Main outcome variables
Maternal age; Preterm labor; Pregnancy number; Fetal sex

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170724035265N2
Registration date: 2018-02-23, 1396/12/04
Registration timing: registered_while_recruiting

Last update: 2018-02-23, 1396/12/04
Update count: 0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Nazanin Hajizadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 912 729 8023
Email address
nazanin.hajizadeh94@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Do not have funds
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of ring pessary and cervical cerclage for preterm birth in twin pregnancies
Public title
Comparative assessment of ring pessary and cervical cerclage for preterm birth in twin pregnancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Twin pregnant women referring to Tehran Taleghani hospital from 2017 to 2019 with cervical length less than 25 mm in the 14th week after measurement by TVS All women will receive proluton. All women aged from 18 to 40
Exclusion criteria:
All women with multiparity, uterus anomaly, chronic disease (RA, CRF, DM, RPL) All women aged more than 40 and under 18 All women with preterm labor delivery, prior cerclage, IUFD, uterus painful contraction
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple randomizing with permutable blocks sized one. Randomization unit is individual. Randomizing tool is SPSS software..
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 committee of Shahid Beheshti University of Medical Sciences and Health Services
Street address
Shahid Arabi Street,Next to Shahid Beheshti University of Medical Sciences,Yemen Street,Velenjak,Chamran highway,
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2017-09-08, 1396/06/17
Ethics committee reference number
IR.SBMU.MSP.REC.1396.468

Health conditions studied

1

Description of health condition studied
Pereterm Delivery
ICD-10 code
O60.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery

Primary outcomes

1

Description
Maternal age
Timepoint
Weekly
Method of measurement
Transvaginal Sonography (TVS)

Secondary outcomes

empty

Intervention groups

1

Description
Twin pregnancies with cervical length shorter than 25 mm, using pessary to prevent preterm delivery.
Category
Treatment - Devices

2

Description
Control group: Twin pregnancies with cervical length shorter than 25 mm, using ceclage to prevent preterm delivery
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Nazanin Hajizadeh
Street address
Shahid Arabi Street, Next to Shahid Beheshti University of Medical Sciences,Yemen Street,Velenjak,Chamran highway,
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Seyyed Ali Ziaei
Street address
Shahid Arabi Street,Next to Taleqani hospital,Yemen Street,Velenjak,Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9969
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahid Beheshti University of Medical Sciences and Health Services
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
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Nazanin Hajizadeh
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 912 729 8023
Fax
+98 21 2243 2570
Email
nazanin.hajizadeh94@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Nasrin Saharkhiz
Position
Obstetrician
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2615 0260
Fax
+98 21 2243 2570
Email
saharkhiz1377@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Nazanin Hajizadeh
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 912 729 8023
Fax
+98 21 2243 2570
Email
nazanin.hajizadeh94@sbmu.ac.ir
Web page address

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
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