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

NCT02059304 | Completed DMC

• 1 other identifier: CLM PrDelivery Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Delivery

Keywords

cervical length; prediction of preterm delivery

Outcome Measures

Primary Outcomes (1)

• Delivery week

  Due to the pregnancy period ( maximum 9 months)

Study Arms (2)

Preterm Delivery

OTHER

Preterm Delivery: Births before the completion of 37 weeks' of gestation.

Device: Measurement of cervical length with embryo transfer catheter

Term Delivery

OTHER

Term Delivery: Births after the completion of 37 weeks' of gestation.

Device: Measurement of cervical length with embryo transfer catheter

Interventions

Measurement of cervical length with embryo transfer catheter DEVICE

Preterm Delivery; Term Delivery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women resulting from ICSI treatment at assisted reproduction center, Acibadem Kayseri Hospital, Turkey.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Kayseri Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Turgut Aydin

  Acıbadem Kayseri Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SCREENING
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Gynecology and Obstetrics

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

TU (1)