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TerminatedNCT00694967Updated Jun 11, 2008

A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix

An interventional study of McDonald cerclage placement and 17 hydroxyprogesterone caproate in Mid Trimester Cervical Shortening, sponsored by Lehigh Valley Hospital. Terminated at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-11.

Sponsored by Lehigh Valley Hospital · Not applicable, Interventional, and Prevention

Why this study was terminated
Interim analysis showed no difference in outcome between treatment groups.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Sex
Female
01

Study summary

We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.

02

Conditions studied

  • Mid Trimester Cervical Shortening

Keywords

  • short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone
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In context

Lead sponsor

Lehigh Valley Hospital is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ultrasonographic evidence of premature dilatation of the internal os
  • Prolapse of the chorio-amniotic membranes into the endocervical canal
  • Functional cervical length less than 25mm
  • Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure

Exclusion criteria

Exclusion Criteria:

  • Any fetal chromosomal or structural anomaly
  • Multiple gestation
  • Known allergy to progesterone
  • Ruptured membranes
  • Vaginal bleeding
  • Intra-amniotic infection (diagnosed clinically or by amniocentesis)
  • Prolapse of endocervical membranes beyond the external cervical os
  • Persistent uterine activity accompanied by cervical change
  • Obstetrically indicated delivery.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Active comparator
    1

    McDonald cerclage

    Procedure: McDonald cerclage placement

  • Active comparator
    2

    17 hydroxyprogesterone caproate

    Drug: 17 hydroxyprogesterone caproate

Interventions

  • ProcedureMcDonald cerclage placement

    Transcervical McDonald cerclage placement

  • Drug17 hydroxyprogesterone caproate

    Weekly 250mg intramuscular injections

06

What researchers measure

Primary outcomes

  1. The primary outcome was spontaneous preterm birth prior to 35 weeks gestation

    Time frame: 11/2003 - 12/2006

Secondary outcomes

  1. Obstetrical complications

    Time frame: 11/2003 - 12/2006

  2. Neonatal morbidity & mortality

    Time frame: 11/2003 --12/2006

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Study locations

1 site
  • Lehigh Valley Hospital
    Allentown, Pennsylvania 18105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00694967
Lead sponsor
Lehigh Valley Hospital
First posted
Jun 11, 2008
Start date
Nov 2003
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Jun 11, 2008

Study contacts

Orion Rust, M.D
principal investigator · Lehigh Valley Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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