Preterm BirthPhase 2/3NCT03077633
Cerclage for Twins With Short Cervix
A Phase 2/3 study testing Cervical Cerclage placement and Vaginal Progesterone in people with Preterm Birth and Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, run by Pediatrix.
Trial summary
A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (</= 15.0mm) between 16w0d to 25w6d. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, Cervical Incompetence
- What is being tested?
- Cervical Cerclage placement and Vaginal Progesterone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 17 Jan 2018
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)
- Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.
- Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.
Who cannot join
- Maternal age less than 18 years
- Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)
- Rupture of membranes, either twin
- One or both twins has no cardiac activity
- One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios
- Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus)
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- Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure
- Symptomatic uterine contractions, 6 or more per hour
- Ongoing bleeding from uterus
- Patient declines to consider cerclage
- Patient declines treatment with vaginal progesterone
- Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.)
- Cerclage is already in place
- Cerclage placement is judged to be technically impossible
- Patient has a history of poor follow-up or poor adherence to physician recommendations
- Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable
- Patient does not give consent to participate in this trial.
About this study
Official title: Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial
A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (</= 15.0mm) between 16w0d to 25w6d.
Read the detailed description
A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.
- Conditions
- Preterm Birth, Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, Cervical Incompetence, Cervical Shortening
- Being tested
- Cervical Cerclage placement, Vaginal Progesterone
- Keywords
- Cerclage, Cervical shortening, Twins, Progesterone
- Medical subject headings
- Premature Birth, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Cerclage placementProcedure or surgery
Cervical Cerclage placement
Vaginal ProgesteroneDrug
Also called Prometrium
200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cerclage + Progesterone | Active comparator | Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab) Receives: Procedure: Cervical Cerclage placement; Drug: Vaginal Progesterone |
| Progesterone | Placebo comparator | Daily administration of vaginal progesterone (200mg tab) Receives: Drug: Vaginal Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of very preterm birth (PTB)
Rate of very PTB (PTB less than 32 weeks)
Measured: Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
Rate of adverse perinatal outcome
The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.
Measured: Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Oct 2017 (estimated)
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Why it stopped: Financial/business decision by Sponsor to not proceed with this study
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.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Cerclage + Progesterone vs. Progesterone alone
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Combs, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077633
- Sponsor's protocol ID
- OBX0038
- Status last verified
- Mar 2018
- First submitted
- 3 Mar 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03077633
- Acronym / sponsor ID
- OBX0038
- Conditions
- Preterm Birth, Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, Cervical Incompetence, Cervical Shortening
- Keywords
- Cerclage, Cervical shortening, Twins, Progesterone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Financial/business decision by Sponsor to not proceed with this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 13 Mar 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.
A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (</= 15.0mm) between 16w0d to 25w6d.
Detailed description
A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: Cerclage + Progesterone vs. Progesterone alone
| Arm | Type | Receives |
|---|---|---|
| Cervical Cerclage + Progesterone | Active comparator | Procedure: Cervical Cerclage placement, Drug: Vaginal ProgesteronePlacement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab) |
| Progesterone | Placebo comparator | Drug: Vaginal ProgesteroneDaily administration of vaginal progesterone (200mg tab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)
- Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.
- Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.
Key exclusion criteria (17 listed)
- Maternal age less than 18 years
- Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)
- Rupture of membranes, either twin
- One or both twins has no cardiac activity
- One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios
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 Cerclage placementCervical Cerclage placement | Procedure or surgery | Cervical Cerclage + Progesterone |
| Vaginal ProgesteroneAlso: Prometrium200mg tab of vaginal progesterone administered daily from time of randomization until delivery. | Drug | Cervical Cerclage + Progesterone, Progesterone |
Primary outcome
Rate of very preterm birth (PTB)
Time frame: Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
Rate of very PTB (PTB less than 32 weeks)
Rate of adverse perinatal outcome
Time frame: Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.
The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Andrew Combs, MD principal investigator
Pediatrix
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cervical Cerclage placement and Vaginal Progesterone in people with Preterm Birth and Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, run by Pediatrix.
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 17 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: withdrawn, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of very preterm birth (PTB) (time frame: Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.). The study lists 2 primary outcomes in all. 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 Mar 2018.