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

NCT01340352 | Completed DMC

• 1 other identifier: 0137-10-EMC
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• length of the cervix in mm.

  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.

  up to 20 month

Study Arms (2)

study group: previous preterm labor

control group:previous term delivery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HaEmek Medical Center delivery room.

You may qualify if:

• Nonpregnant women aged 18-40 years.
• Singelton last pregnancy.
• Last birth, spontaneous premature (24-37 week)
• Last birth at least 3 months ago.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Dep. OB/GYN, Emek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Etty Daniel-Spiegel, MD

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Ultrasound Unit

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: January 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

IL (1)