Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 283 for:    Panama

Cervical Length Pre-induction as a Tool to Predict Vaginal Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02916082
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
First Submitted Date September 25, 2016
First Posted Date September 27, 2016
Last Update Posted Date September 27, 2016
Study Start Date November 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2016)
Vaginal Birth [ Time Frame: 72 hours ]
Number of vaginal births obtained after a measure of cervical length below 2,5 cms.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 25, 2016)
Induction to delivery time [ Time Frame: 72 hours ]
Time (hours) between the application of a prostaglandin and termination of pregnancy (vaginal or cesarean).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cervical Length Pre-induction as a Tool to Predict Vaginal Birth
Official Title Use of Cervical Length Previous to the Use of Prostaglandins as a Tool to Predict Vaginal Birth in Pregnancies With > 41 Weeks Gestation.
Brief Summary To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnancies with a gestational age of 41 weeks or more.
Condition
  • Cervical Length Measurement
  • Pregnancy, Prolonged
Intervention Procedure: Cervical length measurement
Vaginal ultrasound to measure cervical length previous to use of prostaglandins.
Study Groups/Cohorts Prolonged pregnancy
Pregnancies with 41 weeks or more of gestation determined by a reliable last menstrual period or early fetal ultrasound.
Intervention: Procedure: Cervical length measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 25, 2016)
200
Original Actual Enrollment Same as current
Actual Study Completion Date August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 41 weeks or more of gestational age
  • Cervical length measured by a FMF certified physician

Exclusion Criteria:

  • Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Panama
Removed Location Countries  
 
Administrative Information
NCT Number NCT02916082
Other Study ID Numbers 2015-288V2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor Saint Thomas Hospital, Panama
Collaborators Not Provided
Investigators Not Provided
PRS Account Saint Thomas Hospital, Panama
Verification Date September 2016