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Cerclage for Twins With Short Cervix

NCT03077633 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2018-03-21

No results posted yet for this study

Summary

A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (\</= 15.0mm) between 16w0d to 25w6d.

Conditions

  • Preterm Birth
  • Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2
  • Cervical Incompetence
  • Cervical Shortening

Interventions

PROCEDURE

Cervical Cerclage placement

Cervical Cerclage placement

DRUG

Vaginal Progesterone

200mg tab of vaginal progesterone administered daily from time of randomization until delivery.

Sponsors & Collaborators

  • Pediatrix

    lead OTHER

Principal Investigators

  • Andrew Combs, MD · Pediatrix

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-01-17
Completion
2018-01-17
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03077633 on ClinicalTrials.gov