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

H

HaEmek Medical Center, Israel

Status

Completed

Conditions

Preterm Birth

Study type

Observational

Funder types

Other

Identifiers

NCT01340352
0137-10-EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.).

Trial design

62 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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