Preterm BirthPhase 4NCT02746900
Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length
A Phase 4 study testing Cervical cerclage in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Cervical cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Apr 2019
- Phase
- Phase 4
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 ages
- Singleton pregnancy
- Cervical length <=25mm between 18(0) and 23(6) weeks
Who cannot join
- Multiple pregnancy
- Prior spontaneous preterm birth or second trimester losses between 16(0) and 36(6) weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Ruptured membranes
- Major fetal defects
Show all 10Show fewer
- Active vaginal bleeding
- Placenda previa and/or accreta
- Cervical dilation >1.5 cm and/or visible membranes by pelvic exam
- Suspicion of chorioamnionitis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Saccone
Naples, 80129
Gabriele Saccone, 339468517, gabriele.saccone@libero.it
About this study
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
Different strategies have been adopted for prevention of SPTB. Growing interest has focused on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use, does not require anesthesia, can be used in an outpatient clinic setting, and it is easily removed when necessary. However, a recent systematic review and meta-analysis of randomized clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7 However, even if the statistical significance were not reached, they found a reduction in SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%; relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15).
Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without prior SPTB.
Read the detailed description
Investigators aim to conduct a prospective, multicenter, randomized, open-label, clinical trial at Department of Reproductive Science, University of Naples Federico II. All women included in the study will provide a written informed consent to participate in the study before the randomization.
Women with TVU CL ≤25mm who will meet the inclusion criteria will be counselled by an obstetrician regarding the risk of SPTB as per standard of care. The patient will be given ample time to have all questions addressed and consider participation. If the patient agrees to participate in the study, the informed consent form will be signed and a copy will be given to the patient. Women who are eligible and consent to participate in the study will be randomly assigned to one of two groups: cervical cerclage (i.e. intervention group) or standard obstetric management (i.e. control group).
Investigators planned subgroup analyses according to different CL cutoffs (i.e. <=15 and <=10 mm); type of suture; and according to prior history of cervical surgery (i.e. LEEP or cone biopsy).
- Conditions
- Preterm Birth
- Being tested
- Cervical cerclage
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical cerclageProcedure or surgery
McDonald cervical cerclage
| Study group | Role | What they receive |
|---|---|---|
| Cervical cerclage | Experimental | After the woman is placed in the dorsal lithotomy position and the bladder is emptied with a urinary catheter to reduce the chance of bladder injury, surgical preparation with Betadine will be performed. Breisky retractors and Sims retractors will be used to exposure the entire cervix. Sponge ring forceps will be used to optimized visualization of the cervix and provide the necessary countertraction at the suture entry and exit sites. McDonald technique will be performed placing 4-6 bites circumferentially around the cervix. Only one stitch will be used. The suture will be places as high as feasible Receives: Procedure: Cervical cerclage |
| No intervention | No intervention | Bed rest will be not recommended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous preterm birth (SPTB)
Measured: Less than 35 weeks gestation
Secondary outcomes (10)
Spontaneous preterm birth (SPTB)
Measured: Less than 37,34,32,28 and 24 weeks gestation
Gestational age at delivery
mean gestational age at delivery in weeks
Measured: Delivery (at birth)
Latency
mean latency in days (from randomization to delivery)
Measured: Delivery (at birth)
chorioamnionitis
chorioamnionitis histologically proven
Measured: Delivery (at birth)
Birth weight
in grams
Measured: Delivery (at birth)
Admission to neonatal intensive care unit
Measured: Delivery (at birth)
respiratory distress syndrome
Measured: Delivery (at birth)
low birth weight
birth weight <2500 grams
Measured: Delivery (at birth)
intraventricular hemorrhage
grade 3 or 4
Measured: Between birth and 28 days of age
neonatal mortality
death of a live-born baby within the first 28 days of life
Measured: Between birth and 28 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Federico II 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 587 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746900
- Sponsor's protocol ID
- 100/16
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length
- ClinicalTrials.gov ID
- NCT02746900
- Acronym / sponsor ID
- 100/16
- Conditions
- Preterm Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 587 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 21 Apr 2016 (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.
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
Different strategies have been adopted for prevention of SPTB. Growing interest has focused on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use, does not require anesthesia, can be used in an outpatient clinic setting, and it is easily removed when necessary. However, a recent systematic review and meta-analysis of randomized clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7 However, even if the statistical significance were not reached, they found a reduction in SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%; relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15).
Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without prior SPTB.
Detailed description
Investigators aim to conduct a prospective, multicenter, randomized, open-label, clinical trial at Department of Reproductive Science, University of Naples Federico II. All women included in the study will provide a written informed consent to participate in the study before the randomization.
Women with TVU CL ≤25mm who will meet the inclusion criteria will be counselled by an obstetrician regarding the risk of SPTB as per standard of care. The patient will be given ample time to have all questions addressed and consider participation. If the patient agrees to participate in the study, the informed consent form will be signed and a copy will be given to the patient. Women who are eligible and consent to participate in the study will be randomly assigned to one of two groups: cervical cerclage (i.e. intervention group) or standard obstetric management (i.e. control group).
Investigators planned subgroup analyses according to different CL cutoffs (i.e. <=15 and <=10 mm); type of suture; and according to prior history of cervical surgery (i.e. LEEP or cone biopsy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical cerclage | Experimental | Procedure: Cervical cerclageAfter the woman is placed in the dorsal lithotomy position and the bladder is emptied with a urinary catheter to reduce the chance of bladder injury, surgical preparation with Betadine will be performed. Breisky retractors and Sims retractors will be used to exposure the entire cervix. Sponge ring forceps will be used to optimized visualization of the cervix and provide the necessary countertraction at the suture entry and exit sites. McDonald technique will be performed placing 4-6 bites circumferentially around the cervix. Only one stitch will be used. The suture will be places as high as feasible |
| No intervention | No intervention | –Bed rest will be not recommended. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 ages
- Singleton pregnancy
- Cervical length <=25mm between 18(0) and 23(6) weeks
Key exclusion criteria (10 listed)
- Multiple pregnancy
- Prior spontaneous preterm birth or second trimester losses between 16(0) and 36(6) weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Ruptured membranes
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 |
|---|---|---|
| Cervical cerclageMcDonald cervical cerclage | Procedure or surgery | Cervical cerclage |
Primary outcome
Spontaneous preterm birth (SPTB)
Time frame: Less than 35 weeks gestation
10 secondary outcomes
Spontaneous preterm birth (SPTB)
Time frame: Less than 37,34,32,28 and 24 weeks gestation
Gestational age at delivery
Time frame: Delivery (at birth)
Latency
Time frame: Delivery (at birth)
chorioamnionitis
Time frame: Delivery (at birth)
Birth weight
Time frame: Delivery (at birth)
Admission to neonatal intensive care unit
Time frame: Delivery (at birth)
respiratory distress syndrome
Time frame: Delivery (at birth)
low birth weight
Time frame: Delivery (at birth)
intraventricular hemorrhage
Time frame: Between birth and 28 days of age
neonatal mortality
Time frame: Between birth and 28 days of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervical cerclage in people with Preterm Birth, run by Federico II University at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Apr 2016. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous preterm birth (SPTB) (time frame: Less than 35 weeks gestation). 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 21 Apr 2016.