Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?

Completed

• Conditions: Preterm Birth

• Registration Number: NCT01340352
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Working hypothesis and aims:

To investigate the association between cervical length in non-pregnant women, and the risk of premature birth.

The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.

Detailed Description

Women will be invited to undergo an examination in Ultrasound Unit of Department of Obstetrics and Gynecology, HaEmek Medical Center.

Ultrasound examination will be performed using the Voluson E8 device, General Electric.

The cervical length,between the external and internal orifice will be measured using conventional technologies available including: Doppler, three dimensional and two dimensional ultrasound.

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Study Start: 2011-05
• Primary Completion: 2012-05
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-14
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Nonpregnant women aged 18-40 years.
• Singelton last pregnancy.
• Last birth, spontaneous premature (24-37 week)
• Last birth at least 3 months ago.

Exclusion Criteria

• Presence of uterine malformations.

• Sonographic pathologic findings.

• Technical failure (failed appropiate sonographic visualisation)

• Presence of fetal malformations ( in preterm delivery )

• Presence of comorbidities including diabetes, hypertension, collagen disease, thrombophilia

• Presence of risk factors for premature delivery (amniotic fluid infection,

  • cervical surgical treatments - conization, polyhydramnios, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
length of the cervix in mm.	up to 20 month	External orifice location is well-defined anatomically and easy for identification .Internal orifice location will be determined by the level of the uterine arteries at both sides of the cervix.

Trial Locations

Locations (1)

Dep. OB/GYN, Emek Medical Center; 🇮🇱 Afula, Israel