Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Acibadem University
Sponsor:
Information provided by (Responsible Party):
Turgut Aydın, Acibadem University
ClinicalTrials.gov Identifier:
NCT02059304
First received: February 7, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Preterm Delivery
Device: Measurement of cervical length with embryo transfer catheter

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Can Cervical Length Measurement With Embryo Transfer Catheter Predict Preterm Deliveries in ICSI Patients?

Further study details as provided by Acibadem University:

Primary Outcome Measures:
  • Delivery week [ Time Frame: Due to the pregnancy period ( maximum 9 months) ] [ Designated as safety issue: Yes ]

Study Start Date: January 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Preterm Delivery
Preterm Delivery: Births before the completion of 37 weeks' of gestation.
Device: Measurement of cervical length with embryo transfer catheter
Term Delivery
Term Delivery: Births after the completion of 37 weeks' of gestation.
Device: Measurement of cervical length with embryo transfer catheter

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059304

Contacts
Contact: Turgut Aydın drburakyucel@gmail.com
Contact: Burak Yücel drburakyucel@gmail.com

Locations
Turkey
Acıbadem Kayseri Hospital Recruiting
Kayseri, Turkey
Contact: Turgut Aydın       turgut.aydin@acibadem.com.tr   
Principal Investigator: Turgut Aydin         
Sub-Investigator: Burak Yücel         
Sponsors and Collaborators
Acibadem University
Investigators
Principal Investigator: Turgut Aydin Acıbadem Kayseri Hospital
  More Information

No publications provided

Responsible Party: Turgut Aydın, Specialist, Gynecology and Obstetrics, Acibadem University
ClinicalTrials.gov Identifier: NCT02059304     History of Changes
Other Study ID Numbers: CLM PrDelivery Study
Study First Received: February 7, 2014
Last Updated: February 7, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Acibadem University:
cervical length
prediction of preterm delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 22, 2014