Premature BirthLATCHNCT06036446
LATe Cerclage in High-risk Pregnancies (LATCH)
A study testing Cervical cerclage and Vaginal Suppository Progesterone in people with Premature Birth, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks. 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 Suppository Progesterone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2023to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18-50 years old, pregnant, assigned female at birth
- Singleton pregnancy
- TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation
Who cannot join
- Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed >14 weeks, or cotwin pregnancy loss diagnosed >14 weeks
- Cerclage in situ
- Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
- PPROM
- Active vaginal bleeding
- Suspected intraamniotic infection
Show all 10Show fewer
- Major fetal structural abnormality or chromosomal disorder
- Placenta previa or accreta
- Other contraindication to cerclage placement
- Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28204
Lorene Temming, MD, MSCI, 704-448-0305, Lorene.Temming@advocatehealth.org
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Moti Gulersen, MD, MSc, 215-955-5000, moti.gulersen@jefferson.edu
About this study
Official title: Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.
Read the detailed description
Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short TVU CL (≤25mm) is detected between 24 0/7 - 26 6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7 weeks. The primary outcome will be the incidence of preterm birth <37 weeks.
- Conditions
- Premature Birth
- Being tested
- Cervical cerclage, Vaginal Suppository Progesterone
- Keywords
- Cervical length, Short cervix, Shortened cervix, Prematurity, Preterm birth, Viability
- 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
Also called Cerclage
Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
Vaginal Suppository ProgesteroneDrug
Also called Vaginal progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Experimental | Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated. Receives: Procedure: Cervical cerclage; Drug: Vaginal Suppository Progesterone |
| Control | Other | Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. Receives: Drug: Vaginal Suppository Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preterm birth <37 weeks
Measured: At delivery
Secondary outcomes (9)
Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
Measured: At delivery
Gestational age at delivery
Measured: At delivery
Time interval from randomization to delivery
Measured: At delivery
Incidence of preterm prelabor rupture of membranes (PPROM)
Measured: At occurrence up to 36 weeks and 6 days of gestation
Incidence of intraamniotic infection
Defined by either presence of clinical criteria (i.e. includes maternal fever [temperature > 100.4 on two occasions at least 30 minutes apart] and one or more of the following: maternal leukocytosis [white blood cell count > 15,000], purulent cervical drainage, or fetal tachycardia), laboratory testing (positive amniotic fluid test result [gram stain, glucose level [<15], or culture results consistent with infection]), or placental pathology demonstrating histologic evidence of placental infection or inflammation.
Measured: At the time of delivery at any gestational age
Neonatal outcomes: incidence of low birthweight (<2500g)
Measured: At delivery
Neonatal outcomes: incidence of very low birthweight (<1500g)
Measured: At delivery
Neonatal outcomes: incidence of admission to neonatal intensive care unit
Measured: At delivery
Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality
Measured: At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start10 Nov 2023
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
- Masking
- None (open label)
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moti Gulersen, MD, MSc, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036446
- Sponsor's protocol ID
- iRISID-2023-2321
- Acronym
- LATCH
- Status last verified
- May 2026
- First submitted
- 18 Aug 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.
PubMed 36924844
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06036446
- Acronym / sponsor ID
- LATCH / iRISID-2023-2321
- Conditions
- Premature Birth
- Keywords
- Cervical length, Short cervix, Shortened cervix, Prematurity, Preterm birth, Viability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 14 Sep 2023 (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 goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.
Detailed description
Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short TVU CL (≤25mm) is detected between 24 0/7 - 26 6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7 weeks. The primary outcome will be the incidence of preterm birth <37 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 high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Experimental | Procedure: Cervical cerclage, Drug: Vaginal Suppository ProgesteroneCervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated. |
| Control | Other | Drug: Vaginal Suppository ProgesteroneContinuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years old, pregnant, assigned female at birth
- Singleton pregnancy
- TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation
Key exclusion criteria (10 listed)
- Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed >14 weeks, or cotwin pregnancy loss diagnosed >14 weeks
- Cerclage in situ
- Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
- PPROM
- Active 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 |
|---|---|---|
| Cervical cerclageAlso: CerclageTransvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation. | Procedure or surgery | Cerclage |
| Vaginal Suppository ProgesteroneAlso: Vaginal progesteroneContinuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. | Drug | Cerclage, Control |
Primary outcome
Incidence of preterm birth <37 weeks
Time frame: At delivery
9 secondary outcomes
Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
Time frame: At delivery
Gestational age at delivery
Time frame: At delivery
Time interval from randomization to delivery
Time frame: At delivery
Incidence of preterm prelabor rupture of membranes (PPROM)
Time frame: At occurrence up to 36 weeks and 6 days of gestation
Incidence of intraamniotic infection
Time frame: At the time of delivery at any gestational age
Neonatal outcomes: incidence of low birthweight (<2500g)
Time frame: At delivery
Neonatal outcomes: incidence of very low birthweight (<1500g)
Time frame: At delivery
Neonatal outcomes: incidence of admission to neonatal intensive care unit
Time frame: At delivery
Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality
Time frame: At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 36924844Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.
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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.
Moti Gulersen, MD, MSc principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical cerclage and Vaginal Suppository Progesterone in people with Premature Birth, run by Thomas Jefferson University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moti Gulersen, MD, MSc (215-955-5000, moti.gulersen@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preterm birth <37 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 NCT06036446, 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 29 May 2026.