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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01340352
First received: April 20, 2011
Last updated: April 21, 2011
Last verified: April 2011
  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 HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • length of the cervix in mm. [ Time Frame: up to 20 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 62
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated 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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340352

Contacts
Contact: Etty Daniel-Spiegel, MD 97246494034 spiegel_et@clalit.org.il

Locations
Israel
Dep. OB/GYN, Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Etty Daniel-Spiegel, MD    97246494034    spiegel_et@clalit.org.il   
Principal Investigator: Etty Daniel-Spiegl, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Etty Daniel-Spiegel, MD HaEmek medical center
  More Information

No publications provided

Responsible Party: Etty Daniel-Spiegel. MD, Emek Medical Center, Afula, Israel
ClinicalTrials.gov Identifier: NCT01340352     History of Changes
Other Study ID Numbers: 0137-10-EMC
Study First Received: April 20, 2011
Last Updated: April 21, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 24, 2014