Premature BirthNCT02357394
Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
A study testing Arabin Pessary in people with Premature Birth, run by Gene Lee, MD at 2 sites in United States.
Trial summary
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- Arabin Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 1 Apr 2019
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton
- cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
- agrees to refrain from sexual intercourse
Who cannot join
- major fetal anomalies
- painful regular uterine contractions
- active vaginal bleeding
- ruptured membranes
- evidence of chorioamnionitis or other maternal/fetal infectious morbidity
- placenta previa
Show all 9Show fewer
- cervical cerclage in situ
- visual cervical dilation of 2 cm or greater with visible amnion/chorion
- significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
Read the detailed description
This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.
- Conditions
- Premature Birth
- Being tested
- Arabin Pessary
- Keywords
- arabin pessary, 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.
Arabin PessaryDevice
Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.
| Study group | Role | What they receive |
|---|---|---|
| Device: Arabin Pessary | Experimental | Participants randomized to this group will receive the pessary. Receives: Device: Arabin Pessary |
| Standard of Care | No intervention | Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Birth Before 37 Weeks
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Measured: Up to 37 weeks 0 days
Secondary outcomes (16)
Preterm Birth Before 34 Weeks
Number of deliveries before 34 weeks 0 days of gestation
Measured: up to 34 weeks 0 days
Neonatal Composite Morbidity
Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis
Measured: antepartum and up to 28 days after postnatal gestational age of 36 weeks
Neonatal Length of Stay
Total number of days in hospital after birth
Measured: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Admission to Neonatal Intensive Care Unit
Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
Measured: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Total Days in the Neonatal Intensive Care Unit
Number of days a baby spends in the neonatal intensive care unit
Measured: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Duration of Ventilator Support
Number of days a baby requires use of mechanical ventilation
Measured: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Retinopathy of Prematurity Requiring Treatment
Number of newborn with Retinopathy of Prematurity that requires intervention.
Measured: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Birthweight < 1500 Grams
Number of newborns whose birthweight is less than 1500 grams
Measured: at time of birth, expected to be within 4 weeks of due date
Birthweight < 2500 Grams
Number of newborns whose birthweight is less than 2500 grams
Measured: at time of birth, expected to be within 4 weeks of due date
Gestational Age at Delivery
Number of weeks of gestation completed by time of delivery
Measured: at time of birth, expected to be within 4 weeks of due date
Use of Tocolysis
Number of participants required use of tocolytic medication
Measured: participants will be followed for the duration of pregnancy, up to nine months
Use of Antenatal Steroids
Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
Measured: participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Measured: participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding
Number of participants who experienced bleeding from lower genital tract during antepartum period
Measured: participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Measured: participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Number of participants that underwent cesarean delivery
Measured: at time of delivery, expected to be within 4 weeks of due date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion6 Jun 2017
- Study completion1 Apr 2019
Why it stopped: Unable to recruit patients
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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Premature 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gene Lee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor-investigator, Gene Lee, MD, University of Kansas Medical Center
- Investigators
- Gene T Lee, MD, Principal investigator, University of Kansas Medical CenterEugene Y Chang, MD, Principal investigator, Medical University of South CarolinaCarl P Weiner, MD, MBA, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357394
- Sponsor's protocol ID
- KUOBGYN001
- Status last verified
- Oct 2019
- First submitted
- 13 Jan 2015
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Participating in GoNet IPD of pessary for prevention of preterm birth.
Publications
Carreras E, Arevalo S, Bello-Munoz JC, Goya M, Rodo C, Sanchez-Duran MA, Peiro JL, Cabero L. Arabin cervical pessary to prevent preterm birth in severe twin-to-twin transfusion syndrome treated by laser surgery. Prenat Diagn. 2012 Dec;32(12):1181-5. doi: 10.1002/pd.3982. Epub 2012 Oct 11.
PubMed 23055333Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.
PubMed 22475493Ting YH, Lao TT, Wa Law L, Hui SY, Chor CM, Lau TK, Yeung Leung T. Arabin cerclage pessary in the management of cervical insufficiency. J Matern Fetal Neonatal Med. 2012 Dec;25(12):2693-5. doi: 10.3109/14767058.2012.712559. Epub 2012 Aug 22.
PubMed 22871155Sieroszewski P, Jasinski A, Perenc M, Banach R, Oszukowski P. The Arabin pessary for the treatment of threatened mid-trimester miscarriage or premature labour and miscarriage: a case series. J Matern Fetal Neonatal Med. 2009 Jun;22(6):469-72. doi: 10.1080/14767050802531748.
PubMed 19530009Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017.
PubMed 12747228Quaas L, Hillemanns HG, du Bois A, Schillinger H. [The Arabin cerclage pessary--an alternative to surgical cerclage]. Geburtshilfe Frauenheilkd. 1990 Jun;50(6):429-33. doi: 10.1055/s-2008-1026276. German.
PubMed 2198191Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
PubMed 23924878Liem SM, van Baaren GJ, Delemarre FM, Evers IM, Kleiverda G, van Loon AJ, Langenveld J, Schuitemaker N, Sikkema JM, Opmeer BC, van Pampus MG, Mol BW, Bekedam DJ. Economic analysis of use of pessary to prevent preterm birth in women with multiple pregnancy (ProTWIN trial). Ultrasound Obstet Gynecol. 2014 Sep;44(3):338-45. doi: 10.1002/uog.13432. Epub 2014 Aug 7.
PubMed 24898103
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02357394
- Acronym / sponsor ID
- KUOBGYN001
- Conditions
- Premature Birth
- Keywords
- arabin pessary, short cervix
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gene Lee, MDUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- May 2015
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
Detailed description
This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Arabin Pessary | Experimental | Device: Arabin PessaryParticipants randomized to this group will receive the pessary. |
| Standard of Care | No intervention | –Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton
- cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
- agrees to refrain from sexual intercourse
Key exclusion criteria (9 listed)
- major fetal anomalies
- painful regular uterine contractions
- active vaginal bleeding
- ruptured membranes
- evidence of chorioamnionitis or other maternal/fetal infectious morbidity
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 |
|---|---|---|
| Arabin PessaryArabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team. | Device | Device: Arabin Pessary |
Primary outcome
Preterm Birth Before 37 Weeks
Time frame: Up to 37 weeks 0 days
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
16 secondary outcomes
Preterm Birth Before 34 Weeks
Time frame: up to 34 weeks 0 days
Neonatal Composite Morbidity
Time frame: antepartum and up to 28 days after postnatal gestational age of 36 weeks
Neonatal Length of Stay
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Admission to Neonatal Intensive Care Unit
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Total Days in the Neonatal Intensive Care Unit
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Duration of Ventilator Support
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Retinopathy of Prematurity Requiring Treatment
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Birthweight < 1500 Grams
Time frame: at time of birth, expected to be within 4 weeks of due date
Birthweight < 2500 Grams
Time frame: at time of birth, expected to be within 4 weeks of due date
Gestational Age at Delivery
Time frame: at time of birth, expected to be within 4 weeks of due date
Use of Tocolysis
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Use of Antenatal Steroids
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Time frame: at time of delivery, expected to be within 4 weeks of due date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23055333Carreras E, Arevalo S, Bello-Munoz JC, Goya M, Rodo C, Sanchez-Duran MA, Peiro JL, Cabero L. Arabin cervical pessary to prevent preterm birth in severe twin-to-twin transfusion syndrome treated by laser surgery. Prenat Diagn. 2012 Dec;32(12):1181-5. doi: 10.1002/pd.3982. Epub 2012 Oct 11.
- Background: PubMed 22475493Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.
- Background: PubMed 22871155Ting YH, Lao TT, Wa Law L, Hui SY, Chor CM, Lau TK, Yeung Leung T. Arabin cerclage pessary in the management of cervical insufficiency. J Matern Fetal Neonatal Med. 2012 Dec;25(12):2693-5. doi: 10.3109/14767058.2012.712559. Epub 2012 Aug 22.
- Background: PubMed 19530009Sieroszewski P, Jasinski A, Perenc M, Banach R, Oszukowski P. The Arabin pessary for the treatment of threatened mid-trimester miscarriage or premature labour and miscarriage: a case series. J Matern Fetal Neonatal Med. 2009 Jun;22(6):469-72. doi: 10.1080/14767050802531748.
- Background: PubMed 12747228Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017.
- Background: PubMed 2198191Quaas L, Hillemanns HG, du Bois A, Schillinger H. [The Arabin cerclage pessary--an alternative to surgical cerclage]. Geburtshilfe Frauenheilkd. 1990 Jun;50(6):429-33. doi: 10.1055/s-2008-1026276. German.
- Background: PubMed 23924878Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
- Background: PubMed 24898103Liem SM, van Baaren GJ, Delemarre FM, Evers IM, Kleiverda G, van Loon AJ, Langenveld J, Schuitemaker N, Sikkema JM, Opmeer BC, van Pampus MG, Mol BW, Bekedam DJ. Economic analysis of use of pessary to prevent preterm birth in women with multiple pregnancy (ProTWIN trial). Ultrasound Obstet Gynecol. 2014 Sep;44(3):338-45. doi: 10.1002/uog.13432. Epub 2014 Aug 7.
- Individual participant dataSharing planned: Yes. Participating in GoNet IPD of pessary for prevention of preterm birth.
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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.
Gene T Lee, MD principal investigator
University of Kansas Medical Center
Eugene Y Chang, MD principal investigator
Medical University of South Carolina
Carl P Weiner, MD, MBA principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arabin Pessary in people with Premature Birth, run by Gene Lee, MD 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 9 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: stopped early, as of the sponsor's last update on 31 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2019). 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?
Preterm Birth Before 37 Weeks (time frame: Up to 37 weeks 0 days). 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 NCT02357394, which also lists 8 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 31 Oct 2019.