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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340352
First Posted: April 22, 2011
Last Update Posted: June 16, 2015
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.
Information provided by (Responsible Party):
Etty Spiegel, HaEmek Medical Center, Israel
  Purpose

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
Preterm Birth

Study Type: Observational
Study Design: 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?

Further study details as provided by Etty Spiegel, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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.


Enrollment: 62
Study Start Date: May 2011
Study Completion Date: January 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
study group: previous preterm labor
control group:previous term delivery

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.

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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.).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01340352


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

Responsible Party: Etty Spiegel, Director of Ultrasound Unit, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01340352     History of Changes
Other Study ID Numbers: 0137-10-EMC
First Submitted: April 20, 2011
First Posted: April 22, 2011
Last Update Posted: June 16, 2015
Last Verified: June 2015

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