NCT02916082

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

September 25, 2016

Last Update Submit

September 25, 2016

Conditions

Cervical Length MeasurementPregnancy, Prolonged

Keywords

Cervical lengthProlonged pregnancyVaginal birth

Outcome Measures

Primary Outcomes (1)

  • Vaginal Birth

    Number of vaginal births obtained after a measure of cervical length below 2,5 cms.

    72 hours

Secondary Outcomes (1)

  • Induction to delivery time

    72 hours

Study Arms (1)

Prolonged pregnancy

Pregnancies with 41 weeks or more of gestation determined by a reliable last menstrual period or early fetal ultrasound.

Procedure: Cervical length measurement

Interventions

Cervical length measurementPROCEDURE

Vaginal ultrasound to measure cervical length previous to use of prostaglandins.

Prolonged pregnancy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnancies with a gestational age of 41 weeks or more.

You may qualify if:

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

You may not qualify if:

  • Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Research

Study Record Dates

First Submitted

September 25, 2016

First Posted

September 27, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

PA(1)