Placenta PreviaNCT01996345
Vaginal Pessary Versus Expectant Management for Placenta Previa
A study testing Cervical Pessary Placement in people with Placenta Previa, run by Pediatrix at 10 sites in United States.
Trial summary
The purpose of this study is to perform a large multi-center randomized trial comparing the role of vaginal pessary versus expectant management in women with placenta previa between 22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Cervical Pessary Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2016to 5 Sep 2018
- 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 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participant age 18 years or older
- Gestational age between 22w0d and 32w0d, inclusive, at time of enrollment
- Singleton pregnancy
- Complete Placenta Previa
- Intact Membranes
- No allergies to material in pessary
- Plan to deliver at PI's hospital
- Informed consent obtained, signed/dated
Who cannot join
- Active preterm labor
- Nonreassuring fetal heart rate tracing
- Intrauterine fetal death
- Active bleeding (may be enrolled if hemostatic >48 hours)
- Ruptured membranes
- Any fetal condition likely to cause serious neonatal morbidity independent of gestational age: Fetal malformation likely to require surgery, Fetal malformation involving vital organs, Fetal viral infection, Hydrops fetalis,
Show all 9Show fewer
- Known Uterine Anomaly
- Cervical Cerclage present at time of enrollment
- Maternal condition that warrant continued hospitalization (example severe preeclampsia, Diabetes out of control, maternal heart disease)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
Denver Health and Hospital Authority
Denver, Colorado, 95008
Baylor/Texas Children's Hospital & Pavilion
Houston, Texas, 77030
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428
Norton Kosair Children's Hospital
Louisville, Kentucky, 40202
Tulane - Lakeside Hospital for Women and Children
Metairie, Louisiana, 70001
University of South Alabama Medical Center
Mobile, Alabama, 36617
Touro Infirmary
New Orleans, Louisiana, 70115
Good Samaritan Hospital
San Jose, California, 95008
Swedish Medical Center
Seattle, Washington, 98122-4307
About this study
Official title: Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa
The purpose of this study is to perform a large multi-center randomized trial comparing the role of vaginal pessary versus expectant management in women with placenta previa between 22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes will assess duration of antepartum admission, total blood loss, gestational age at delivery, type of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use of a vaginal pessary in patients presenting with placenta previa between 22-32 weeks will decrease delivery prior to 36 weeks as compared to expectantly managing these patients.
Read the detailed description
While the use of pessary in this scenario has not been previously assessed, it is reasonable to infer, from the data for use of pessary to prevent preterm birth, and the data regarding the efficacy of cervical cerclage in reducing bleeding and preterm birth in patients with placenta previa to this clinical conundrum. If cerclage improves pregnancy outcomes in patients with placenta previa, the use of a vaginal pessary should be a less-invasive but similarly efficacious alternative to maintain cervical length. The purpose of this study is to compare two treatment options reasonably used in clinical practice. Use of cervical pessary is not expected to increase antenatal costs beyond the minimal cost of the pessary. Additionally, given the results of the available clinical trials on cerclage maintaining cervical length and decreasing bleeding, this procedure has the potential to decrease the cost of both antepartum admissions for bleeding and neonatal care.
A substantial number of women with placenta previa will not hemorrhage until they reach the third trimester, thus, by allowing for enrollment and pessary placement as late as 32w0d, the intervention may be applied to the broadest "at risk" population. As previously mentioned literature on the use of cerclage in patients with placenta previa and short cervix are limited by a reduced number of eligible subjects and concern over safety issues has not been assuaged by these small studies. As pessary placement appears to carry little if any risk based on a number of published studies, eligibility can be expanded to any cervical length.
- Conditions
- Placenta Previa
- Being tested
- Cervical Pessary Placement
- Keywords
- Placenta Previa, Vaginal Pessary, Premature Birth
- Medical subject headings
- Placenta Previa, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Pessary PlacementProcedure or surgery
For the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Pessary Placement | Experimental | For the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option. Receives: Procedure: Cervical Pessary Placement |
| Expectant Managment | No intervention | Each participant will have standard care for placenta previa. This is the same care that a patient with a placenta previa would ordinarily receive even if she were not participating in the trial. The trial's participating investigators agree that the management outlined in this section is standard management for placenta previa. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa.
This outcome, a decrease in the number of delivery that occur before 36 weeks of pregnancy who have a diagnosed placenta previa. The gestational age is noted at the time of birth.
Measured: day of birth
Secondary outcomes (4)
Need for packed red blood cells or hematologic product replacement
note the number of blood transfusions the baby received from birth until 60 days post birth
Measured: from birth to 60 days
Neonate or Fetal Death
death of fetus or newborn up to 60 days post delivery
Measured: From time of trial entry to 60 days post birth (approximately 34 weeks)
Neonatal Outcomes
Including birthweight, neonatal death, composite neonatal morbidity (any of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death.) and specific neonatal morbidities including: Apgar <3 at 5 min, ICU admission, , cord pH, 7.1.
Measured: From Birth to 60 days of Age
Any adverse reactions to the cervical pessary.
unexpected adverse reaction such as cervical trauma, infection, allergy
Measured: from 0 to as many as 18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startOct 2016
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Why it stopped: Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetrix Medical Group
- Responsible party
- Sponsor
- Investigators
- Thomas Garite, MD, Principal investigator, Obstetrix Medical GroupIrene Stafford, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996345
- Sponsor's protocol ID
- OBX0028
- Status last verified
- Sep 2018
- First submitted
- 14 Nov 2013
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa
- ClinicalTrials.gov ID
- NCT01996345
- Acronym / sponsor ID
- OBX0028
- Conditions
- Placenta Previa
- Keywords
- Placenta Previa, Vaginal Pessary, Premature Birth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Obstetrix Medical Group
- Study start
- Oct 2016 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 27 Nov 2013 (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 purpose of this study is to perform a large multi-center randomized trial comparing the role of vaginal pessary versus expectant management in women with placenta previa between 22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes will assess duration of antepartum admission, total blood loss, gestational age at delivery, type of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use of a vaginal pessary in patients presenting with placenta previa between 22-32 weeks will decrease delivery prior to 36 weeks as compared to expectantly managing these patients.
Detailed description
While the use of pessary in this scenario has not been previously assessed, it is reasonable to infer, from the data for use of pessary to prevent preterm birth, and the data regarding the efficacy of cervical cerclage in reducing bleeding and preterm birth in patients with placenta previa to this clinical conundrum. If cerclage improves pregnancy outcomes in patients with placenta previa, the use of a vaginal pessary should be a less-invasive but similarly efficacious alternative to maintain cervical length. The purpose of this study is to compare two treatment options reasonably used in clinical practice. Use of cervical pessary is not expected to increase antenatal costs beyond the minimal cost of the pessary. Additionally, given the results of the available clinical trials on cerclage maintaining cervical length and decreasing bleeding, this procedure has the potential to decrease the cost of both antepartum admissions for bleeding and neonatal care.
A substantial number of women with placenta previa will not hemorrhage until they reach the third trimester, thus, by allowing for enrollment and pessary placement as late as 32w0d, the intervention may be applied to the broadest "at risk" population. As previously mentioned literature on the use of cerclage in patients with placenta previa and short cervix are limited by a reduced number of eligible subjects and concern over safety issues has not been assuaged by these small studies. As pessary placement appears to carry little if any risk based on a number of published studies, eligibility can be expanded to any cervical length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Pessary Placement | Experimental | Procedure: Cervical Pessary PlacementFor the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option. |
| Expectant Managment | No intervention | –Each participant will have standard care for placenta previa. This is the same care that a patient with a placenta previa would ordinarily receive even if she were not participating in the trial. The trial's participating investigators agree that the management outlined in this section is standard management for placenta previa. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant age 18 years or older
- Gestational age between 22w0d and 32w0d, inclusive, at time of enrollment
- Singleton pregnancy
- Complete Placenta Previa
- Intact Membranes
Key exclusion criteria (9 listed)
- Active preterm labor
- Nonreassuring fetal heart rate tracing
- Intrauterine fetal death
- Active bleeding (may be enrolled if hemostatic >48 hours)
- Ruptured 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 |
|---|---|---|
| Cervical Pessary PlacementFor the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option. | Procedure or surgery | Cervical Pessary Placement |
Primary outcome
Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa.
Time frame: day of birth
This outcome, a decrease in the number of delivery that occur before 36 weeks of pregnancy who have a diagnosed placenta previa. The gestational age is noted at the time of birth.
4 secondary outcomes
Need for packed red blood cells or hematologic product replacement
Time frame: from birth to 60 days
Neonate or Fetal Death
Time frame: From time of trial entry to 60 days post birth (approximately 34 weeks)
Neonatal Outcomes
Time frame: From Birth to 60 days of Age
Any adverse reactions to the cervical pessary.
Time frame: from 0 to as many as 18 weeks.
Results and safety
The study was stopped early (reason given: Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Sponsors WebsiteLink provided by the sponsor.
- 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.
Thomas Garite, MD principal investigator
Obstetrix Medical Group
Irene Stafford, MD principal investigator
Baylor College of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Pessary Placement in people with Placenta Previa, run by Pediatrix at 10 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 8 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 stopped early (reason given: Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants.). Results are not available in the source record.
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?
Decrease Delivery Prior to 36 weeks in patients with a gestational age of 22.0- 32.0 presenting with placenta previa. (time frame: day of birth). 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 27 Sep 2018.