Short Cervical LengthPhase 3PROSPECTNCT02518594
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
A Phase 3 study testing Vaginal progesterone and Arabin Pessary in people with Short Cervical Length, run by The George Washington University Biostatistics Center at 16 sites in United States.
Trial summary
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Short Cervical Length
- What is being tested?
- Vaginal progesterone and Arabin Pessary
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,311 participants
- Where
- 16 sitesUnited States
- Study dates
- 13 Nov 2015to 18 Feb 2025
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
- Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- Cervical length on transvaginal examination of less than 30 mm by a study certified sonographer.
Who cannot join
- Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization. There is no lower threshold of cervical length measurement threshold on ultrasound that is an exclusion criterion.
- Monoamniotic gestation, due to increased risk of adverse pregnancy outcome
- Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome
- Evidence of severe IUGR (intrauterine growth restriction) (<5th percentile for gestational age) in either fetus
- Fetal anomaly in either twin or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project EDC (estimated date of conception) must be performed prior to randomization to evaluate the fetuses for anomalies.
- Placenta previa, because of risk of bleeding and high potential for indicated preterm birth
Show all 23Show fewer
- Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement.
- Symptomatic, untreated vaginal or cervical infection, also because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized.
- Active, unhealed herpetic lesion on labia minora, vagina, or cervix due to the potential for significant patient discomfort or increasing genital tract viral spread. Once lesion(s) heal and the patient is asymptomatic, she may be randomized. History of herpes is not an exclusion.
- Rupture of membranes due to likelihood of pregnancy loss and preterm delivery as well as the risk of ascending infection which could be increased with pessary placement
- More than six contractions per hour reported or documented prior to randomization. It is not necessary to place the patient on a tocodynamometer
- Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery which is unlikely to be affected by progesterone
- Any fetal/maternal condition which would require invasive in-utero assessment or treatment, for example significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia
- Major maternal medical illness associated with increased risk for adverse pregnancy outcome or indicated preterm birth (treated hypertension requiring more than one agent, pre-gestational treatment for diabetes prior to pregnancy, chronic renal insufficiency failure defined by creatinine >1.4 mg/dL, carcinoma of the breast, conditions treated with chronic oral glucocorticoid therapy. Specifically, patients with seizure disorders, HIV, and other medical conditions not specifically associated with an increased risk of indicated preterm birth are not excluded. Prior cervical cone/LOOP/LEEP is not an exclusion criterion.
- Planned cerclage or cerclage already in place since it would preclude placement of a pessary
- Planned indicated delivery prior to 35 weeks
- Planned or actual progesterone treatment of any type or form after 15 weeks 6 days during the current pregnancy
- Allergy to progesterone, silicone, or excipients in the study drug, including peanuts or peanut oil in the study drug or placebo
- Known, suspected or history of breast cancer because breast cancer is a contraindication to the active study medication.
- Known liver dysfunction or disease because liver disease is a contraindication to the active study medication.
- Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
- Prenatal care or delivery planned elsewhere unless the study visits can be made as scheduled and complete outcome information can be obtained
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35294
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University-Prentice Hospital
Chicago, Illinois, 60611
Case Western Reserve University
Cleveland, Ohio, 44109
Ohio State University
Columbus, Ohio, 43210
University of Colorado
Denver, Colorado, 80045
Duke University
Durham, North Carolina, 27710
University of Texas - Galveston
Galveston, Texas, 77555
University of Texas - Houston
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas
Columbia University
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Brown University
Providence, Rhode Island, 02905
University of Utah Medical Center
Salt Lake City, Utah, 84132
The Regents of the University of California, San Francisco
San Francisco, California
About this study
Official title: A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
Read the detailed description
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
Multiple gestation increases the risk of preterm delivery. Babies born preterm have increased rates of neonatal mortality and long-term neurodevelopmental morbidities. Short cervical length is known to be an important risk factor for spontaneous preterm birth and to occur more frequently in women with a twin gestation. Although there is no evidence that progesterone reduces the risk of preterm birth in multifetal gestation, there is evidence that progesterone reduces the risk of prematurity in singleton gestations complicated with a short cervix. The Arabin pessary has also been shown to reduce the risk of preterm birth among singletons with a short cervix, and in a secondary subgroup analysis of a recent study of the use of pessary in multiple gestations, women with a cervical length < 25th percentile had a significantly reduced risk of the primary composite neonatal adverse outcome. Secondary analysis of studies of vaginal progesterone in multiple gestation with a short cervix also suggest a possible beneficial effect on preterm delivery.
- Conditions
- Short Cervical Length
- Being tested
- Vaginal progesterone, Placebo, Arabin Pessary
- Keywords
- women, cervical length of less than 30 millimeters, carrying twins, short cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesteroneDrug
Also called Prometrium
200mg micronized vaginal progesterone softgel capsule, daily from randomization to < 35 wks
PlaceboDrug
placebo softgel capsule, daily from randomization to < 35 wks
Arabin PessaryDevice
placement and management of an Arabin Pessary from randomization to < 35 wks
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Active comparator | vaginal progesterone capsule Receives: Drug: Vaginal progesterone |
| Placebo | Placebo comparator | placebo capsule Receives: Drug: Placebo |
| Arabin Pessary | Active comparator | Arabin Pessary Receives: Device: Arabin Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation
Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation
Measured: From randomization to 35 weeks gestation (a period of up to 19 weeks)
Secondary outcomes (15)
Days From Randomization to Delivery (or Fetal Demise)
Days from the time of randomization (16-23 weeks gestation) to delivery or death of the fetus.
Measured: Randomization to delivery (a period of up to 26 weeks)
Gestational Age at Delivery or Fetal Death
Gestational age at the time of delivery or death
Measured: Randomization to delivery (a period of up to 26 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation
Preterm delivery or fetal loss of either twin prior to 28 weeks gestation
Measured: From randomization to up to 28 weeks gestation (a period if up to 12 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation
Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation
Measured: From randomization to 32 weeks gestation (a period of up to 16 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation
Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation
Measured: randomization to 37 weeks gestation (a period of up to 21 weeks)
Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation
Spontaneous preterm delivery (following preterm labor or pPROM) before 32 weeks gestation
Measured: randomization to 32 weeks gestation (a period of up to 16 weeks)
Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation
Spontaneous preterm delivery (following preterm labor or pPROM) before 35 weeks gestation
Measured: randomization to 35 weeks gestation (a period of up to 19 weeks)
Number of Participants With Indicated Preterm Delivery for < 35 Weeks
Preterm delivery prior to 35 weeks gestation with medical indications
Measured: randomization to 35 weeks gestation (a period of up to 19 weeks)
Number of Participants With Cesarean Delivery
Delivery by cesarean
Measured: Randomization to delivery (a period of up to 26 weeks)
Number of Fetal, Neonatal or Infant Deaths
Number of fetal, neonatal or infant deaths
Measured: From randomization to up to 28 days post birth (a period of up to 30 weeks)
Number of Neonates Small for Gestational Age < 5th Percentile
The number of neonates whose birthweight compared with gestational age at delivery was less than the 5th percentile, as assessed by sex and race, using United States birth certificate data.
Measured: randomization to delivery (a period of up to 26 weeks)
Number of Neonates With the Composite Neonatal Outcome
The number of neonates diagnosed with any one of fetal or neonatal death or Respiratory Distress Syndrome, Grade 3 or 4 Intraventricular Hemorrhage, Periventricular Leukomalacia, Stage 2 or 3 Necrotizing Enterocolitis, Bronchopulmonary Dysplasia, Stage III or higher Retinopathy of Prematurity, or early onset sepsis.
IVH grades III or IV are as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system. The number of neonates diagnosed with NEC, defined as modified Bell Stage 2 or 3 where stage 2 represents clinical signs and symptoms with pneumatosis intestinalis on radiographs and stage 3 is defined as advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation. The stages of Retinopathy of Prematurity range from 1 (mild) to 5 (severe).
Measured: Birth to neonatal discharge or death, whichever is first (up to 70 weeks)
Number of Neonates Admitted to Intensive Care (NICU) or Intermediate Care
The number of neonates admitted to intensive care (NICU) or intermediate care out of all liveborn infants.
Measured: Birth to the time of NICU or Intermediate Care Admission, whichever came first (a maximum of 10 days)
Length of Neonatal Hospital Stay in Days
Number of days the neonate was in the hospital
Measured: admission to hospital discharge (a median of 12 days with a maximum of 490 days)
Length of Stay in Neonatal Intensive Care (NICU) or Intermediate Care in Days
Length of stay in neonatal intensive care (NICU) or intermediate care
Measured: admission to discharge from NICU or intermediate care (a median of 28 days, with a maximum of 491 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study start13 Nov 2015
- Primary completion15 Dec 2024
- Study completion18 Feb 2025
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.
- Other trials for Short Cervical LengthStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomly assigned to study drug (200 mg micronized progesterone daily), placebo study drug appearing identical to progesterone capsule, or Arabin pessary.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,311 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Washington University Biostatistics Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Joseph Biggio, MD, Study chair, Maternal Fetal Medicine Units (MFMU) NetworkMonica Longo, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518594
- Sponsor's protocol ID
- HD36801-PROSPECT
- Other IDs
- U24HD036801, UG1HD087230, UG1HD027869, UG1HD027915, UG1HD034208, UG1HD040500, UG1HD040485, UG1HD053097
- Acronym
- PROSPECT
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2015
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The dataset will be shared per NIH policy after the completion and publication of the main analyses.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
- ClinicalTrials.gov ID
- NCT02518594
- Acronym / sponsor ID
- PROSPECT / HD36801-PROSPECT
- Conditions
- Short Cervical Length
- Keywords
- women, cervical length of less than 30 millimeters, carrying twins, short cervix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,311 participants (actual)
- Lead sponsor
- The George Washington University Biostatistics CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
Detailed description
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
Multiple gestation increases the risk of preterm delivery. Babies born preterm have increased rates of neonatal mortality and long-term neurodevelopmental morbidities. Short cervical length is known to be an important risk factor for spontaneous preterm birth and to occur more frequently in women with a twin gestation. Although there is no evidence that progesterone reduces the risk of preterm birth in multifetal gestation, there is evidence that progesterone reduces the risk of prematurity in singleton gestations complicated with a short cervix. The Arabin pessary has also been shown to reduce the risk of preterm birth among singletons with a short cervix, and in a secondary subgroup analysis of a recent study of the use of pessary in multiple gestations, women with a cervical length < 25th percentile had a significantly reduced risk of the primary composite neonatal adverse outcome. Secondary analysis of studies of vaginal progesterone in multiple gestation with a short cervix also suggest a possible beneficial effect on preterm delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Women will be randomly assigned to study drug (200 mg micronized progesterone daily), placebo study drug appearing identical to progesterone capsule, or Arabin pessary.
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Active comparator | Drug: Vaginal progesteronevaginal progesterone capsule |
| Placebo | Placebo comparator | Drug: Placeboplacebo capsule |
| Arabin Pessary | Active comparator | Device: Arabin PessaryArabin Pessary |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
- Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- Cervical length on transvaginal examination of less than 30 mm by a study certified sonographer.
Key exclusion criteria (23 listed)
- Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization. There is no lower threshold of cervical length measurement threshold on ultrasound that is an exclusion criterion.
- Monoamniotic gestation, due to increased risk of adverse pregnancy outcome
- Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome
- Evidence of severe IUGR (intrauterine growth restriction) (<5th percentile for gestational age) in either fetus
- Fetal anomaly in either twin or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project EDC (estimated date of conception) must be performed prior to randomization to evaluate the fetuses for anomalies.
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 |
|---|---|---|
| Vaginal progesteroneAlso: Prometrium200mg micronized vaginal progesterone softgel capsule, daily from randomization to < 35 wks | Drug | Progesterone |
| Placeboplacebo softgel capsule, daily from randomization to < 35 wks | Drug | Placebo |
| Arabin Pessaryplacement and management of an Arabin Pessary from randomization to < 35 wks | Device | Arabin Pessary |
Primary outcome
Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation
Time frame: From randomization to 35 weeks gestation (a period of up to 19 weeks)
Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation
15 secondary outcomes
Days From Randomization to Delivery (or Fetal Demise)
Time frame: Randomization to delivery (a period of up to 26 weeks)
Gestational Age at Delivery or Fetal Death
Time frame: Randomization to delivery (a period of up to 26 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation
Time frame: From randomization to up to 28 weeks gestation (a period if up to 12 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation
Time frame: From randomization to 32 weeks gestation (a period of up to 16 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation
Time frame: randomization to 37 weeks gestation (a period of up to 21 weeks)
Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation
Time frame: randomization to 32 weeks gestation (a period of up to 16 weeks)
Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation
Time frame: randomization to 35 weeks gestation (a period of up to 19 weeks)
Number of Participants With Indicated Preterm Delivery for < 35 Weeks
Time frame: randomization to 35 weeks gestation (a period of up to 19 weeks)
Number of Participants With Cesarean Delivery
Time frame: Randomization to delivery (a period of up to 26 weeks)
Number of Fetal, Neonatal or Infant Deaths
Time frame: From randomization to up to 28 days post birth (a period of up to 30 weeks)
Number of Neonates Small for Gestational Age < 5th Percentile
Time frame: randomization to delivery (a period of up to 26 weeks)
Number of Neonates With the Composite Neonatal Outcome
Time frame: Birth to neonatal discharge or death, whichever is first (up to 70 weeks)
Number of Neonates Admitted to Intensive Care (NICU) or Intermediate Care
Time frame: Birth to the time of NICU or Intermediate Care Admission, whichever came first (a maximum of 10 days)
Length of Neonatal Hospital Stay in Days
Time frame: admission to hospital discharge (a median of 12 days with a maximum of 490 days)
Length of Stay in Neonatal Intensive Care (NICU) or Intermediate Care in Days
Time frame: admission to discharge from NICU or intermediate care (a median of 28 days, with a maximum of 491 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The dataset will be shared per NIH policy after the completion and publication of the main analyses.
Related trials for Short Cervical Length
Recruiting
LATe Cerclage in High-risk Pregnancies (LATCH)
Premature Birth
Recruiting
Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
Preterm Birth, Short Cervix
Recruiting
Routine Activity and Preterm Delivery Risk in Women With a Short Cervix
Cervical Shortening
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.
Joseph Biggio, MD study chair
Maternal Fetal Medicine Units (MFMU) Network
Monica Longo, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal progesterone and Arabin Pessary in people with Short Cervical Length, run by The George Washington University Biostatistics Center at 16 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 23 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 10 Mar 2026). 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?
Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation (time frame: From randomization to 35 weeks gestation (a period of up to 19 weeks)). 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 25 Jun 2026.