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

NCT ID: NCT01340352

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group: previous preterm labor

No interventions assigned to this group

control group:previous term delivery

No interventions assigned to this group

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Etty Spiegel

Director of Ultrasound Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Etty Daniel-Spiegel, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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Dep. OB/GYN, Emek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0137-10-EMC

Identifier Type: -

Identifier Source: org_study_id

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