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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340352
Recruitment Status : Completed
First Posted : April 22, 2011
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):
Etty Spiegel, 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.

Condition or disease
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
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : January 2015

study group: previous preterm labor
control group:previous term delivery

Primary Outcome Measures :
  1. length of the cervix in mm. [ Time Frame: 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HaEmek Medical Center delivery room.

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340352

Dep. OB/GYN, Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Principal Investigator: Etty Daniel-Spiegel, MD haemek medical center

Responsible Party: Etty Spiegel, Director of Ultrasound Unit, HaEmek Medical Center, Israel Identifier: NCT01340352     History of Changes
Other Study ID Numbers: 0137-10-EMC
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

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