Premature BirthPhase 4COLORSNCT03251729
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
A Phase 4 study testing Cervical cerclage and Vaginal progesterone in people with Premature Birth, run by Thomas Jefferson University at 3 sites in 2 countries.
Trial summary
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Cervical cerclage and Vaginal progesterone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Sep 2017to 20 Feb 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 year old or older
- Singleton pregnancy
- No prior SPTB or second trimester losses between 160 and 366 weeks
- TVU CL ≤25mm between 180 and 236 weeks
Who cannot join
- Multiple pregnancy
- Prior SPTB or second trimester losses between 160 and 366 weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Rupture membranes
- Major fetal anomaly or aneuploidy
Show all 10Show fewer
- Active vaginal bleeding
- Placenta previa and/or accreta
- Cervical dilation >1.0 cm and/or visible membranes by pelvic exam
- Suspicion of chorioamnionitis
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
University of Naples Federico II
Naples
University Cattolica del S. Cuore
Rome
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth
Read the detailed description
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks
- Conditions
- Premature Birth
- Being tested
- Cervical cerclage, Vaginal progesterone
- Keywords
- cerclage, preterm birth, short cervix
- 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
Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
Vaginal progesteroneDrug
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Experimental | Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. Receives: Procedure: Cervical cerclage; Drug: Vaginal progesterone |
| Control | Other | Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. Receives: Drug: Vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth <35 weeks
Incidence of spontaneous preterm birth less than 35 weeks
Measured: At delivery
Secondary outcomes (12)
Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks
Measured: At delivery
Mean gestational age at delivery
Measured: At delivery
Histologically proven clinical chorioamnionitis
Measured: At delivery
Neonatal outcomes: birth weight
Measured: At delivery
Neonatal outcomes: low birth weight (<2500g),
Measured: At delivery
Neonatal outcomes: admission to intensive care nursery
Measured: At delivery
Neonatal outcomes: length of neonatal hospital admission
Measured: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: respiratory distress syndrome
Measured: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: IVH grade 3 or 4
Measured: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: retinopathy of prematurity
Measured: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: bronchopulmonary dysplasia
Measured: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: neonatal mortality
Measured: 28 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start22 Sep 2017
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Model description
- Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251729
- Sponsor's protocol ID
- 17D.164
- Acronym
- COLORS
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon completion of appropriate data sharing agreements
Publications
Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.
PubMed 28295722Boelig RC, Tersigni C, Di Simone N, Saccone G, Facchinetti F, Scambia G, Berghella V. Cerclage in singleton pregnancies with no prior spontaneous preterm birth and short cervix: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Apr;7(4):101602. doi: 10.1016/j.ajogmf.2025.101602. Epub 2025 Jan 27.
PubMed 39880123
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. 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: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03251729
- Acronym / sponsor ID
- COLORS / 17D.164
- Conditions
- Premature Birth
- Keywords
- cerclage, preterm birth, short cervix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth
Detailed description
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Experimental | Procedure: Cervical cerclage, Drug: Vaginal progesteroneCervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. |
| Control | Other | Drug: Vaginal progesteroneVaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 year old or older
- Singleton pregnancy
- No prior SPTB or second trimester losses between 160 and 366 weeks
- TVU CL ≤25mm between 180 and 236 weeks
Key exclusion criteria (10 listed)
- Multiple pregnancy
- Prior SPTB or second trimester losses between 160 and 366 weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Rupture 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 cerclageTransvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks | Procedure or surgery | Cerclage |
| Vaginal progesteroneVaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks | Drug | Cerclage, Control |
Primary outcome
Preterm birth <35 weeks
Time frame: At delivery
Incidence of spontaneous preterm birth less than 35 weeks
12 secondary outcomes
Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks
Time frame: At delivery
Mean gestational age at delivery
Time frame: At delivery
Histologically proven clinical chorioamnionitis
Time frame: At delivery
Neonatal outcomes: birth weight
Time frame: At delivery
Neonatal outcomes: low birth weight (<2500g),
Time frame: At delivery
Neonatal outcomes: admission to intensive care nursery
Time frame: At delivery
Neonatal outcomes: length of neonatal hospital admission
Time frame: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: respiratory distress syndrome
Time frame: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: IVH grade 3 or 4
Time frame: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: retinopathy of prematurity
Time frame: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: bronchopulmonary dysplasia
Time frame: at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: neonatal mortality
Time frame: 28 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 28295722Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.
- Derived from this study: PubMed 39880123Boelig RC, Tersigni C, Di Simone N, Saccone G, Facchinetti F, Scambia G, Berghella V. Cerclage in singleton pregnancies with no prior spontaneous preterm birth and short cervix: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Apr;7(4):101602. doi: 10.1016/j.ajogmf.2025.101602. Epub 2025 Jan 27.
- Individual participant dataSharing planned: Yes. IPD will be shared upon completion of appropriate data sharing agreements
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervical cerclage and Vaginal progesterone in people with Premature Birth, run by Thomas Jefferson University at 3 sites in 2 countries.
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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preterm birth <35 weeks (time frame: At delivery). 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 NCT03251729, which also lists 2 linked publications.
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 19 Apr 2024.