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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Dep. OB/GYN, Emek Medical Center

Afula, 18101, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2015
First posted: Apr 22, 2011
Registry last updated: Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed