Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix
Primary Purpose
Preterm Birth, Twin Pregnancy With Antenatal Problem, Cervical Shortening
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cervical cerclage
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- Age between 18-45 years.
- Dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm with or without internal os dilatation ≥10 mm at 14-20 weeks gestational age.
- Asymptomatic.
Exclusion Criteria:
- Triplets and quadruplets.
- Monochorionic twins.
- Threatened/ inevitable miscarriage
- Bulging membranes through the external os.
- Extremes of age.
- Major fetal anomalies.
- Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis… etc.
- Fetal demise.
- Fetal reduction in the current pregnancy.
Sites / Locations
- Faculty of medicine, Zagazig UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cerclage group
No Cerclage group
Arm Description
cervical cerclage between 14 and 20 weeks will be done by one of the three authors.
Routine follow up without cerclage
Outcomes
Primary Outcome Measures
The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm
Rate of preterm births stratified by gestational age inside the included women
Secondary Outcome Measures
Subgroup analysis for the risk of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤15 mm
subgroup analysis for rate of preterm births for very short cervix
The incidence of miscarriage.
rate of missed, inevitable and complete miscarriages
Incidence of cervico-vaginal infection
Rate of infections diagnosed during pregnancy by patient complaint, clinical examination and confirmed by culture and sensitivity).
Neonatal outcomes in both groups
Rate of untoward early neonatal outcomes respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05338164
Brief Title
Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix
Official Title
Protective Value of Cervical Cerclage Against Preterm Birth in Twin Pregnancy With Short Cervix. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.
Detailed Description
Introduction Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant mortality.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.
Rationale:
Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Twin Pregnancy With Antenatal Problem, Cervical Shortening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerclage group
Arm Type
Experimental
Arm Description
cervical cerclage between 14 and 20 weeks will be done by one of the three authors.
Arm Title
No Cerclage group
Arm Type
No Intervention
Arm Description
Routine follow up without cerclage
Intervention Type
Procedure
Intervention Name(s)
cervical cerclage
Intervention Description
McDonald cervical cerclage will be applied using Mersaline braided tape with double needle. Single stitch (4 bites) will be applied as close as possible to the level of internal os. The Knot will be put either anterior or posterior according to the surgeon desire.
Primary Outcome Measure Information:
Title
The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm
Description
Rate of preterm births stratified by gestational age inside the included women
Time Frame
Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Subgroup analysis for the risk of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤15 mm
Description
subgroup analysis for rate of preterm births for very short cervix
Time Frame
Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Title
The incidence of miscarriage.
Description
rate of missed, inevitable and complete miscarriages
Time Frame
Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year
Title
Incidence of cervico-vaginal infection
Description
Rate of infections diagnosed during pregnancy by patient complaint, clinical examination and confirmed by culture and sensitivity).
Time Frame
after confirmation of infection through study completion, an average of 1 year
Title
Neonatal outcomes in both groups
Description
Rate of untoward early neonatal outcomes respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission
Time Frame
early neonatal through study completion, an average of 1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant ladies
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18-45 years.
Dichorionic twins.
Transvaginal sonographic cervical length is <25 mm with or without internal os dilatation ≥10 mm at 14-20 weeks gestational age.
Asymptomatic.
Exclusion Criteria:
Triplets and quadruplets.
Monochorionic twins.
Threatened/ inevitable miscarriage
Bulging membranes through the external os.
Extremes of age.
Major fetal anomalies.
Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis… etc.
Fetal demise.
Fetal reduction in the current pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hytham Atia, M.D
Phone
+966538308500
Email
hythamatia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Lashiin, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amro El Nemr, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Zagazig University
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hytham Atia, M.D.
Email
hythamatia@gmail.com
First Name & Middle Initial & Last Name & Degree
Amro El Nemr, M.D.
First Name & Middle Initial & Last Name & Degree
Mohamed Lashin, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix
We'll reach out to this number within 24 hrs