Preterm BirthPrePPyNCT01380158
Preventing Preterm Birth With a Pessary
A study testing Cup pessary (Bioteque America, Inc) in people with Preterm Birth, run by Medstar Health Research Institute at 3 sites in United States.
Trial summary
The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Cup pessary (Bioteque America, Inc)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2011to Oct 2012
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
- Women ages 18 to 45 years of age
Who cannot join
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
- Presence of prophylactic cervical cerclage
- Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
- Painful regular uterine contractions, or ruptured membranes
- Visual cervical dilation of 2cm or greater and visible membranes.
- Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Franklin Square Hospital
Baltimore, Maryland, 21237
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.
- Conditions
- Preterm Birth
- Being tested
- Cup pessary (Bioteque America, Inc)
- Keywords
- pessary, preterm birth, short cervix, cervical incompetence
- 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.
Cup pessary (Bioteque America, Inc)Device
Placement of cup pessary in the vagina after randomization
| Study group | Role | What they receive |
|---|---|---|
| Pessary use during pregnancy | Experimental | Device: Cup pessary Receives: Device: Cup pessary (Bioteque America, Inc) |
| Expectant management | No intervention | Expectant Management + weekly intramuscular progesterone injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
delivery prior to 37 weeks of gestation
Gestational age at birth will be recorded
Measured: within the first 30 days after delivery of the neonate
Secondary outcomes (7)
Rate of birth less than seven days from randomization
Gestational age at birth will be recorded
Measured: within the first 30 days after delivery of the neonate
Previable birth (<24 weeks)
Gestational age at birth will be recorded
Measured: within the first 30 days after delivery of the neonate
Perinatal death
defined as either a stillbirth or postnatal death prior to hospital discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Low birth weight
Birthweight at delivery will be recorded
Measured: within the first 30 days after delivery of the neonate
Major adverse neonatal outcomes
intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Need for neonatal special care
ventilation, phototherapy, treatment for sepsis, blood transfusion
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of complications due to pessary
Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.
Measured: Every 4 weeks while pregnant with pessary in situ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita W Driggers, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380158
- Sponsor's protocol ID
- 2010-225
- Acronym
- PrePPy
- Status last verified
- Jun 2011
- First submitted
- 15 Jun 2011
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
PubMed 8569824Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.
PubMed 19788970Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.
PubMed 12802023Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. doi: 10.1097/00006250-196805000-00024. No abstract available.
PubMed 5646408Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. doi: 10.1097/00003081-196608000-00011. No abstract available.
PubMed 5944837Arabin 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 12747228Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachow J. [Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery]. Ginekol Pol. 2003 Oct;74(10):1029-36. Polish.
PubMed 14669390
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Preterm Birth With a Pessary
- ClinicalTrials.gov ID
- NCT01380158
- Acronym / sponsor ID
- PrePPy / 2010-225
- Conditions
- Preterm Birth
- Keywords
- pessary, preterm birth, short cervix, cervical incompetence
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- 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 primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pessary use during pregnancy | Experimental | Device: Cup pessary (Bioteque America, Inc)Device: Cup pessary |
| Expectant management | No intervention | –Expectant Management + weekly intramuscular progesterone injections |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
- Women ages 18 to 45 years of age
Key exclusion criteria (6 listed)
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
- Presence of prophylactic cervical cerclage
- Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
- Painful regular uterine contractions, or ruptured membranes
- Visual cervical dilation of 2cm or greater and visible 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 |
|---|---|---|
| Cup pessary (Bioteque America, Inc)Placement of cup pessary in the vagina after randomization | Device | Pessary use during pregnancy |
Primary outcome
delivery prior to 37 weeks of gestation
Time frame: within the first 30 days after delivery of the neonate
Gestational age at birth will be recorded
7 secondary outcomes
Rate of birth less than seven days from randomization
Time frame: within the first 30 days after delivery of the neonate
Previable birth (<24 weeks)
Time frame: within the first 30 days after delivery of the neonate
Perinatal death
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Low birth weight
Time frame: within the first 30 days after delivery of the neonate
Major adverse neonatal outcomes
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Need for neonatal special care
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of complications due to pessary
Time frame: Every 4 weeks while pregnant with pessary in situ
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 17 Feb 2021.
- Background: PubMed 8569824Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
- Background: PubMed 19788970Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.
- Background: PubMed 12802023Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.
- Background: PubMed 5646408Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. doi: 10.1097/00006250-196805000-00024. No abstract available.
- Background: PubMed 5944837Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. doi: 10.1097/00003081-196608000-00011. No abstract available.
- 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 14669390Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachow J. [Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery]. Ginekol Pol. 2003 Oct;74(10):1029-36. Polish.
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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.
Rita W Driggers, MD principal investigator
Medstar Health Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cup pessary (Bioteque America, Inc) in people with Preterm Birth, run by Medstar Health Research Institute at 3 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 2 inclusion and 6 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 17 Feb 2021. 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 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?
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?
delivery prior to 37 weeks of gestation (time frame: within the first 30 days after delivery of the neonate). 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 NCT01380158, which also lists 7 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 17 Feb 2021.