NCT02680093

Brief Summary

Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up. additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery outcomes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

January 21, 2016

Last Update Submit

February 8, 2016

Conditions

Pregnancy, Prolonged

Outcome Measures

Primary Outcomes (1)

  • Time interval between measurement of cervical length and delivery

    According to our local protocol post date surveillance is stated from 40+0 weeks of gestation. Each gravida undergoes vaginal examination using sonographic measurement of cervical length(in mm) using trans-vaginal sonar.

    2 weeks.

Secondary Outcomes (3)

  • Delivery with in 48 hours

    48 hours

  • Delivery with in 7 days

    7 days

  • Necessity of labor induction duo to post date

    2 weeks

Study Arms (1)

Cervical length in pregnant women.

Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date.

Other: Cervical length in pregnant women.

Interventions

Cervical length in pregnant women.OTHER

Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up. additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery out comes.

Cervical length in pregnant women.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant Women beyond the date of birth in conservative monitoring and prenatal follow-up.

You may qualify if:

  • Age 18-50 .
  • Individual fetus
  • The dating of gestational age based on first- trimester ultrasonography or by last menstrual
  • Gestational age between 39 weeks and 0 days to 41 weeks and 6 days .
  • The pregnant women is not in pain ( VAS \<3 ) while signing on consent to participate.
  • Normal fetal monitoring measures and Sonar
  • Expectant mother is in active labor
  • Consent to participate

You may not qualify if:

  • Multi-pass Pregnancy
  • Without accurate dating of gestational age based on first- trimester ultrasonography or by last menstrual
  • Indicators for abnormal fetal monitoring and / or Sonar
  • Active labor
  • pain ( VAS \> = 3 )
  • Expectant mother does not agree to participate or delivery if consent was given earlier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • yariv yogev, professor

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yariv yogev, professor

CONTACT

97236925603yarivy@tlvmc.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 11, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share