Cervical InsufficiencyRECIANCT01114516
Multifactorial Approach to Emergent Cerclage
A study testing Indomethacin and antibiotics (cefazolin or clindamycin) in people with Cervical Insufficiency, run by Northwestern University at 1 site in United States.
Trial summary
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Insufficiency
- What is being tested?
- Indomethacin and antibiotics (cefazolin or clindamycin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GA 16+0 to 23+6 weeks
- Singleton gestation
- Presence of cervical dilation as diagnosed on digital examination
- Intact membranes
Who cannot join
- Age <18 years
- Allergy to NSAIDs
- Renal disease
- Allergy to penicillins AND clindamycin
- Currently on antibiotics or indomethacin for any reason
- HIV positive
Show all 10Show fewer
- Pregnancies complicated by fetal congenital anomalies
- Preterm premature rupture of membranes
- Fever of 100.4 degrees Fahrenheit or higher
- Any patient having received a therapeutic cerclage during the current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role in Emergent Cerclage of Indomethacin and Antibiotics
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.
The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.
- Conditions
- Cervical Insufficiency
- Being tested
- Indomethacin and antibiotics (cefazolin or clindamycin)
- Keywords
- cervical insufficiency
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin and antibiotics (cefazolin or clindamycin)Drug
Also called indocin, cleocin, ancef
q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | emergent cerclage with no peri-operative antibiotics or indomethacin |
| indomethacin and antibiotics | Experimental | perioperative antibiotics and indomethacin Receives: Drug: Indomethacin and antibiotics (cefazolin or clindamycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Measured: 24 weeks
Secondary outcomes (4)
Gestational Latency of More Than 28 Days
The frequency of achieving a gestational latency of more than 28 days
Measured: 28 days postpartum
Gestational Age at Delivery
Median gestational age at delivery
Measured: 24 weeks
Neonatal Morbidity and Mortality
Days spent in the neonatal intensive care unit
Measured: 1 year
Birthweight
Median birthweight
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical InsufficiencyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Grobman, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114516
- Sponsor's protocol ID
- STU00019610
- Acronym
- RECIA
- Status last verified
- Nov 2014
- First submitted
- 29 Apr 2010
- Last updated
- 7 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228.
PubMed 24807330
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role in Emergent Cerclage of Indomethacin and Antibiotics
- ClinicalTrials.gov ID
- NCT01114516
- Acronym / sponsor ID
- RECIA / STU00019610
- Conditions
- Cervical Insufficiency
- Keywords
- cervical insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Posted 10 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.
The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –emergent cerclage with no peri-operative antibiotics or indomethacin |
| indomethacin and antibiotics | Experimental | Drug: Indomethacin and antibiotics (cefazolin or clindamycin)perioperative antibiotics and indomethacin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GA 16+0 to 23+6 weeks
- Singleton gestation
- Presence of cervical dilation as diagnosed on digital examination
- Intact membranes
Key exclusion criteria (10 listed)
- Age <18 years
- Allergy to NSAIDs
- Renal disease
- Allergy to penicillins AND clindamycin
- Currently on antibiotics or indomethacin for any reason
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 |
|---|---|---|
| Indomethacin and antibiotics (cefazolin or clindamycin)Also: indocin, cleocin, ancefq8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin | Drug | indomethacin and antibiotics |
Primary outcome
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Time frame: 24 weeks
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
4 secondary outcomes
Gestational Latency of More Than 28 Days
Time frame: 28 days postpartum
Gestational Age at Delivery
Time frame: 24 weeks
Neonatal Morbidity and Mortality
Time frame: 1 year
Birthweight
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24807330Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indomethacin and antibiotics (cefazolin or clindamycin) in people with Cervical Insufficiency, run by Northwestern University 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 10 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: finished, as of the sponsor's last update on 7 Nov 2014. 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?
Yes. Results are posted in the registry (first posted 10 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114516, which also lists 1 linked publication.
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 7 Nov 2014.