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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • Dep. OB/GYN, Emek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

HaEmek Medical Center delivery room.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
study group: previous preterm labor
control group:previous term delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Etty Daniel-Spiegel, MD, Haemek Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimate): April 22, 2011

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 14, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 0137-10-EMC