Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients
Primary Purpose
Preterm Delivery
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Measurement of cervical length with embryo transfer catheter
Sponsored by

About this trial
This is an interventional screening trial for Preterm Delivery focused on measuring cervical length, prediction of preterm delivery
Eligibility Criteria
Inclusion Criteria:
- Pregnant women resulting from ICSI treatment at assisted reproduction center, Acibadem Kayseri Hospital, Turkey.
Exclusion Criteria:
- missing outcome data, multiple pregnancies, miscarriages during the first trimester, cigarette smoking, PTD history, progesterone use after 12 weeks, cerclage performed, termination (iatrogenic delivery) and PTDs due to preeclampsia
Sites / Locations
- Acıbadem Kayseri Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Preterm Delivery
Term Delivery
Arm Description
Preterm Delivery: Births before the completion of 37 weeks' of gestation.
Term Delivery: Births after the completion of 37 weeks' of gestation.
Outcomes
Primary Outcome Measures
Delivery week
Secondary Outcome Measures
Full Information
NCT ID
NCT02059304
First Posted
February 7, 2014
Last Updated
December 19, 2014
Sponsor
Acibadem University
1. Study Identification
Unique Protocol Identification Number
NCT02059304
Brief Title
Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients
Official Title
Can Cervical Length Measurement With Embryo Transfer Catheter Predict Preterm Deliveries in ICSI Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to examine the potential value of cervical length (CL) measurement with embryo transfer catheter in the prediction of spontaneous preterm deliveries in intracytoplasmic sperm injection (ICSI) cycles.
Preterm birth is the leading cause of perinatal death and handicap in children. It is clear that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there is an estimated two-fold increased risk following ICSI.
CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been shown that the measurement of CL on pregnancy is an effective method for identification of the group at high risk for PTD.
In embryo transfer, catheter is placed the through cervical canal. The method we will use in this study, CL measurement with transfer catheter, will give more precise results than measurement with ultrasound.
No study has been performed to evaluate the prediction of PTD by analyzing measurements of CL, preconceptionally. Our study will be the first in this topic.
There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related to the gestation at which treatment is initiated. If we know the risk of PTD before gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that also increase the relative risk of PTD, in ICSI pregnancies.
Detailed Description
Cervical length measurement protocol: The physician inserted a sterile Collin vaginal speculum; the cervix was exposed and gently cleaned with sterile gauze pads. Cervical mucus was gently removed with a syringe if abundant. A nurse concomitantly performed transabdominal ultrasound scan. Estimated cervical length is determined before transfer procedure. The Sure View Wallace Embryo Replacement Catheter (No. CE118; Smith Medical, Hythe, Kent, UK). There are marked lines on the surface of catheter that show distances to half centimeters. The catheter has a sliding guide fixed at external cervical os. Correct position of the catheter is replaced guide on external os, and guide's endpoint is on internal cervical os. In relation to the internal os was verified on the scan. If required, re-fixation of sliding guide to external os will also be performed. After loading embryos, the length between the guide and the end of catheter will be noted.
Data collection protocol: We will obtain data on pregnancy outcome from the hospital computerized records or the records from family practitioners of the women. We will record birth weeks as major outcome. The obstetric records of all patients will be examined to determine whether any exclusion criteria are present.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery
Keywords
cervical length, prediction of preterm delivery
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Preterm Delivery
Arm Type
Other
Arm Description
Preterm Delivery: Births before the completion of 37 weeks' of gestation.
Arm Title
Term Delivery
Arm Type
Other
Arm Description
Term Delivery: Births after the completion of 37 weeks' of gestation.
Intervention Type
Device
Intervention Name(s)
Measurement of cervical length with embryo transfer catheter
Primary Outcome Measure Information:
Title
Delivery week
Time Frame
Due to the pregnancy period ( maximum 9 months)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women resulting from ICSI treatment at assisted reproduction center, Acibadem Kayseri Hospital, Turkey.
Exclusion Criteria:
missing outcome data, multiple pregnancies, miscarriages during the first trimester, cigarette smoking, PTD history, progesterone use after 12 weeks, cerclage performed, termination (iatrogenic delivery) and PTDs due to preeclampsia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgut Aydin
Organizational Affiliation
Acıbadem Kayseri Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem Kayseri Hospital
City
Kayseri
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients
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