Mid Trimester Cervical ShorteningNCT00694967
A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix
A study testing McDonald cerclage placement and 17 hydroxyprogesterone caproate in people with Mid Trimester Cervical Shortening, run by Lehigh Valley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mid Trimester Cervical Shortening
- What is being tested?
- McDonald cerclage placement and 17 hydroxyprogesterone caproate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any fetal chromosomal or structural anomaly
- Multiple gestation
- Known allergy to progesterone
- Ruptured membranes
- Vaginal bleeding
- Intra-amniotic infection (diagnosed clinically or by amniocentesis)
Show all 9Show fewer
- Prolapse of endocervical membranes beyond the external cervical os
- Persistent uterine activity accompanied by cervical change
- Obstetrically indicated delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
About this study
Official title: Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy
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.
- Conditions
- Mid Trimester Cervical Shortening
- Being tested
- McDonald cerclage placement, 17 hydroxyprogesterone caproate
- Keywords
- short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McDonald cerclage placementProcedure or surgery
Transcervical McDonald cerclage placement
17 hydroxyprogesterone caproateDrug
Weekly 250mg intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | McDonald cerclage Receives: Procedure: McDonald cerclage placement |
| 2 | Active comparator | 17 hydroxyprogesterone caproate Receives: Drug: 17 hydroxyprogesterone caproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was spontaneous preterm birth prior to 35 weeks gestation
Measured: 11/2003 - 12/2006
Secondary outcomes (2)
Obstetrical complications
Measured: 11/2003 - 12/2006
Neonatal morbidity & mortality
Measured: 11/2003 --12/2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startNov 2003
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Interim analysis showed no difference in outcome between treatment groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Trimester Cervical ShorteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Orion Rust, M.D, Principal investigator, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694967
- Sponsor's protocol ID
- 2003103
- Status last verified
- Jun 2008
- First submitted
- 7 Jun 2008
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy
- ClinicalTrials.gov ID
- NCT00694967
- Acronym / sponsor ID
- 2003103
- Conditions
- Mid Trimester Cervical Shortening
- Keywords
- short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed no difference in outcome between treatment groups.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: McDonald cerclage placementMcDonald cerclage |
| 2 | Active comparator | Drug: 17 hydroxyprogesterone caproate17 hydroxyprogesterone caproate |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Any fetal chromosomal or structural anomaly
- Multiple gestation
- Known allergy to progesterone
- Ruptured membranes
- Vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McDonald cerclage placementTranscervical McDonald cerclage placement | Procedure or surgery | 1 |
| 17 hydroxyprogesterone caproateWeekly 250mg intramuscular injections | Drug | 2 |
Primary outcome
The primary outcome was spontaneous preterm birth prior to 35 weeks gestation
Time frame: 11/2003 - 12/2006
2 secondary outcomes
Obstetrical complications
Time frame: 11/2003 - 12/2006
Neonatal morbidity & mortality
Time frame: 11/2003 --12/2006
Results and safety
The study was stopped early (reason given: Interim analysis showed no difference in outcome between treatment groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orion Rust, M.D principal investigator
Lehigh Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McDonald cerclage placement and 17 hydroxyprogesterone caproate in people with Mid Trimester Cervical Shortening, run by Lehigh Valley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed no difference in outcome between treatment groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was spontaneous preterm birth prior to 35 weeks gestation (time frame: 11/2003 - 12/2006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2008.