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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340352
• Other study ID #: 0137-10-EMC
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: June 14, 2015
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
Israel	Dep. OB/GYN, Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of the cervix in mm.	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.	up to 20 month	No