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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
History of Changes

April 20, 2011
April 21, 2011
May 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01340352 on ClinicalTrials.gov Archive Site
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Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

HaEmek Medical Center delivery room.
Preterm Birth
Not Provided
  • study group: previous preterm labor
  • control group:previous term delivery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
62
December 2012
May 2012   (final data collection date for primary outcome measure)

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.).
Female
18 Years to 40 Years
No
Contact: Etty Daniel-Spiegel, MD 97246494034 spiegel_et@clalit.org.il
Israel
 
NCT01340352
0137-10-EMC
Yes
Etty Daniel-Spiegel. MD, Emek Medical Center, Afula, Israel
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Etty Daniel-Spiegel, MD HaEmek medical center
HaEmek Medical Center, Israel
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP