Preterm BirthNCT04147117
Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population
A study testing Cervical pessary in people with Preterm Birth, run by Hospital Sant Joan de Deu at 1 site in Spain.
Trial summary
DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Cervical pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2017to 31 Dec 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy.
- Age > 18 years old.
- Gestational age between 18.0 -23.6 weeks of gestation.
- Asymptomatic singleton pregnancies, with at least one of the following:
- Previous spontaneous preterm delivery or PPROM (23 - 34.6 weeks).
- Previous spontaneous second trimester miscarriage (16.0-22.6 weeks).
Show all 9Show fewer
- Previous surgery on uterine cervix.
- Uterine malformation.
- Able to sign informed consent form.
Who cannot join
- Congenital, chromosomal abnormalities or stillbirth in current pregnancy before randomization.
- Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
- Symptomatic high-risk women or preterm prelabor rupture of membranes (PROM) in the current pregnancy.
- Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
- Pregnant women with an indication to perform a cervical cerclage, prior to study inclusion.
- Cerclage in situ.
- Active vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Sant Joan de Déu. BCNatal | Barcelona Center for Maternal Fetal and Neonatal Medicine | Hospital Clínic - Hospital Sant Joan de Déu
Barcelona, 08950
Sílvia Irene Ferrero Martínez, MD, PhD, +34932532100, sferrero@sjdhospitalbarcelona.org
Sílvia Irene Ferrero Martínez, MD, PhD
About this study
DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women.
METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations.
MAIN OUTCOME: sPTB <370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.
Read the detailed description
Spontaneous preterm birth (sPB) is still a leading cause of neonatal and infant death and responsible of neonatal morbidity as cerebral palsy. In spite of improvements of neonatal care, rates of preterm birth have not changed in the recent 10 years.
Clinical risk factors for preterm birth include: 1) Demographic characteristics such a low socioeconomic status, poor antenatal care, malnutrition or extremes in maternal age; 2) Behavioral factors including smoking, illicit drug abuse, alcohol consumption or heavy physical work; 3) Obstetric history including uterine malformation, previous preterm labor or preterm rupture of membranes (PROM), previous cervical surgery, late miscarriage >16-17 weeks; 4) Aspects of the current pregnancy as multiple pregnancy, genital tract bleeding or infection, Preterm Rupture of Membranes (PROM), short cervix and others.
In nulliparous women with no previous pregnancies or fetal losses >16 weeks, screening based on clinical history (maternal racial origin, age, height, smoking status and method of conception) could detect about 20% of sPB. In women with previous pregnancies at or beyond 16 weeks the detection rate is doubled by incorporating obstetric history.
The risks for women with a previous spontaneous preterm birth with a normal cervix in pregnancy are not negligible. It has been suggested that there is a continuum risk dependent on absolute cervical length while other authors showed that absolute length of cervix above 25mm had little impact on the risk of preterm birth before 35 weeks. A posterior study has not identified any clinical or obstetric risk factors in high-risk women with cervical length greater than 25mm that could help to identify those who will subsequently have a spontaneous preterm birth.
The risk of preterm birth is inversely related to cervical length (CL) as measured by ultrasound. Current options for the management of short cervix in singleton pregnancies are: vaginal progesterone, with proved benefit; cervical cerclage in high risk and short cervix, and cervical pessary.
Cervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall.
Three randomized trials involving women with singleton low risk pregnancies and short cervix provided controversial results regarding the effect of cervical pessary on the rate of sPB before 34 weeks; in one trial, involving 380 women, the rate of this outcome was significantly lower with a pessary than with no pessary (6% vs 27%); in another trial, involving 108 women, there was no significant effect (9.4% vs 5.5%, respectively) and in the largest trial, involving 935 women, no benefits were found (12.9% vs 11.3%, respectively).
Nowadays high-risk population with normal cervix is managed by cervical length surveillance and physical activity restriction, as progesterone has not a proved benefit in women at risk because of previous history but normal cervix.
Cervical pessary has not been tested specifically in high risk population. In PECEP study a total number of 42 patients (11% of each group) had at least one previous preterm birth. Authors did not report differences in the risk of preterm birth before 34 weeks in this subgroup. In Nicolaides study, 154 patients had previous birth before 37 weeks: 70 were treated with pessary and 84 with expectant management. The reported risk of birth before 34 weeks was 10.1% and 19.5%, respectively. In spite of the increased risk in expectant group, these differences were not significant (OR 0.47 (0.18-1.21) p= 0.12). In both trials, women included has short cervix.
Even that group of women with previous preterm birth were included in the previous trials, pessary has not been proved in a specific group of population with previous history of preterm birth or uterine-cervical factors. Therefore, there is a lack of information in this topic.
- Conditions
- Preterm Birth
- Being tested
- Cervical pessary
- Keywords
- Preterm Birth, Cervical Pessary, Obstetrical history, Cervical length
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical pessaryDevice
Cervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall.
| Study group | Role | What they receive |
|---|---|---|
| Pessary Group | Experimental | A pessary certified is inserted through the vagina with the woman in recumbent position and is placed around the cervix.
Correct placement of the pessary is assessed by ultrasound. Patients on the pessary group are specially awarded about adverse symptoms and the need of immediate report in case of pain, bleeding and symptomatic contractions.
The pessary is not removed when symptoms of infection occur after pessary insertion, but appropriate treatment is given.
The pessary is removed at 37 weeks of pregnancy. Indications for pessary removal before 37 weeks are: active vaginal bleeding, premature labor not responding to tocolysis or severe patient discomfort. Receives: Device: Cervical pessary |
| Control group | No intervention | Current management for the follow-up of these women in the PBPC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous preterm birth before 37 weeks of gestation
Delivery < 37.0 weeks of gestation (Yes/No)
Measured: 3 years
Secondary outcomes (20)
Preterm birth 34 weeks
Birth before 34 weeks of gestation (Yes/No)
Measured: 5 months
Preterm birth 28 weeks
Birth before 28 weeks of gestation (Yes/No)
Measured: 5 months
PPROM before 34 weeks
Preterm premature rupture of membranes before 34 weeks (Yes/No)
Measured: 5 months
Threatened preterm labor
Number of admissions for threatened preterm labor <34weeks of gestation
Measured: 5 months
Cervical trauma
Serious cervical or vaginal trauma (Yes/No)
Measured: 5 months
Pessary tolerance
Intolerance to pessary (Yes/No)
Measured: 5 months
Infection
Vaginal infection (Yes/No)
Measured: 5 months
Progesterone co-treatment
Need for progesterone co-treatment (Yes/No)
Measured: 5 months
Choriomanionitis
Clinical chorioamnionitis (Yes/No)
Measured: 5 months
Maternal mortality or morbidity
Maternal mortality or severe morbidity (Yes/No)
Measured: 5 months
Neonatal birthweight
Birth weight in grams
Measured: 5 months
Neonatal outcomes APGAR
5 min APGAR score < 7 (Yes/No)
Measured: 5 months
Neonatal outcomes umbilical artery pH
Umbilical artery pH at delivery <7.1 (Yes/No)
Measured: 5 months
Neonatal outcomes NICU
Need for NICU admission (Yes/No)
Measured: 5 months
Neonatal outcomes for respiratory support
Need for respiratory support (Yes/No)
Measured: 5 months
Neonatal outcomes SDR
Respiratory distress syndrome (Yes/No)
Measured: 5 months
Neonatal outcomes IVH
Intraventricular haemorrhage (Yes/No)
Measured: 5 months
Neonatal outcomes NEC
Necrotizing enterocolitis (Yes/No)
Measured: 5 months
Neonatal outcomes. Death
Neonatal death (Yes/No)
Measured: 5 months
Neonatal outcomes. Sepsis
Neonatal sepsis (Yes/No)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start25 Oct 2017
- Primary completion31 Mar 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sant Joan de Deu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Irene Ferrero Martínez, MD,PhD, Principal investigator, BCNatal | Hospital Sant Joan de Déu - Hospital ClínicMontse Palacio Riera, MD,PhD, Study director, BCNatal | Hospital Clínic- Hospital Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147117
- Sponsor's protocol ID
- PIC-35-17
- Status last verified
- Jun 2020
- First submitted
- 16 Oct 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beta J, Akolekar R, Ventura W, Syngelaki A, Nicolaides KH. Prediction of spontaneous preterm delivery from maternal factors, obstetric history and placental perfusion and function at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):75-83. doi: 10.1002/pd.2662.
PubMed 21210482Sotiriadis A, Papatheodorou S, Kavvadias A, Makrydimas G. Transvaginal cervical length measurement for prediction of preterm birth in women with threatened preterm labor: a meta-analysis. Ultrasound Obstet Gynecol. 2010 Jan;35(1):54-64. doi: 10.1002/uog.7457.
PubMed 20014326Celik E, To M, Gajewska K, Smith GC, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Cervical length and obstetric history predict spontaneous preterm birth: development and validation of a model to provide individualized risk assessment. Ultrasound Obstet Gynecol. 2008 May;31(5):549-54. doi: 10.1002/uog.5333.
PubMed 18432605Owen J, Szychowski JM, Hankins G, Iams JD, Sheffield JS, Perez-Delboy A, Berghella V, Wing DA, Guzman ER; Vaginal Ultrasound Trial Consortium. Does midtrimester cervical length >/=25 mm predict preterm birth in high-risk women? Am J Obstet Gynecol. 2010 Oct;203(4):393.e1-5. doi: 10.1016/j.ajog.2010.06.025. Epub 2010 Aug 12.
PubMed 20708169Care AG, Sharp AN, Lane S, Roberts D, Watkins L, Alfirevic Z. Predicting preterm birth in women with previous preterm birth and cervical length >/= 25 mm. Ultrasound Obstet Gynecol. 2014 Jun;43(6):681-6. doi: 10.1002/uog.13241.
PubMed 24186101Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.
PubMed 22284156Berghella V, Mackeen AD. Cervical length screening with ultrasound-indicated cerclage compared with history-indicated cerclage for prevention of preterm birth: a meta-analysis. Obstet Gynecol. 2011 Jul;118(1):148-155. doi: 10.1097/AOG.0b013e31821fd5b0.
PubMed 21691173Owen 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 19788970Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA. Cervical pessary for preventing preterm birth. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007873. doi: 10.1002/14651858.CD007873.pub3.
PubMed 23728668Goya 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 22475493Hui SY, Chor CM, Lau TK, Lao TT, Leung TY. Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial. Am J Perinatol. 2013 Apr;30(4):283-8. doi: 10.1055/s-0032-1322550. Epub 2012 Aug 8.
PubMed 22875662Nicolaides KH, Syngelaki A, Poon LC, de Paco Matallana C, Plasencia W, Molina FS, Picciarelli G, Tul N, Celik E, Lau TK, Conturso R. Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial. Am J Obstet Gynecol. 2016 Jan;214(1):3.e1-9. doi: 10.1016/j.ajog.2015.08.051. Epub 2015 Aug 28.
PubMed 26321037Orzechowski KM, Boelig RC, Berghella V. Cervical Length Screening in Asymptomatic Women at High Risk and Low Risk for Spontaneous Preterm Birth. Clin Obstet Gynecol. 2016 Jun;59(2):241-51. doi: 10.1097/GRF.0000000000000195.
PubMed 27015227O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96. doi: 10.1002/uog.5158.
PubMed 17899572DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.
PubMed 17899571
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population
- ClinicalTrials.gov ID
- NCT04147117
- Acronym / sponsor ID
- PIC-35-17
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Cervical Pessary, Obstetrical history, Cervical length
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Hospital Sant Joan de DeuUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Oct 2019 (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.
DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women.
METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations.
MAIN OUTCOME: sPTB <370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.
Detailed description
Spontaneous preterm birth (sPB) is still a leading cause of neonatal and infant death and responsible of neonatal morbidity as cerebral palsy. In spite of improvements of neonatal care, rates of preterm birth have not changed in the recent 10 years.
Clinical risk factors for preterm birth include: 1) Demographic characteristics such a low socioeconomic status, poor antenatal care, malnutrition or extremes in maternal age; 2) Behavioral factors including smoking, illicit drug abuse, alcohol consumption or heavy physical work; 3) Obstetric history including uterine malformation, previous preterm labor or preterm rupture of membranes (PROM), previous cervical surgery, late miscarriage >16-17 weeks; 4) Aspects of the current pregnancy as multiple pregnancy, genital tract bleeding or infection, Preterm Rupture of Membranes (PROM), short cervix and others.
In nulliparous women with no previous pregnancies or fetal losses >16 weeks, screening based on clinical history (maternal racial origin, age, height, smoking status and method of conception) could detect about 20% of sPB. In women with previous pregnancies at or beyond 16 weeks the detection rate is doubled by incorporating obstetric history.
The risks for women with a previous spontaneous preterm birth with a normal cervix in pregnancy are not negligible. It has been suggested that there is a continuum risk dependent on absolute cervical length while other authors showed that absolute length of cervix above 25mm had little impact on the risk of preterm birth before 35 weeks. A posterior study has not identified any clinical or obstetric risk factors in high-risk women with cervical length greater than 25mm that could help to identify those who will subsequently have a spontaneous preterm birth.
The risk of preterm birth is inversely related to cervical length (CL) as measured by ultrasound. Current options for the management of short cervix in singleton pregnancies are: vaginal progesterone, with proved benefit; cervical cerclage in high risk and short cervix, and cervical pessary.
Cervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall.
Three randomized trials involving women with singleton low risk pregnancies and short cervix provided controversial results regarding the effect of cervical pessary on the rate of sPB before 34 weeks; in one trial, involving 380 women, the rate of this outcome was significantly lower with a pessary than with no pessary (6% vs 27%); in another trial, involving 108 women, there was no significant effect (9.4% vs 5.5%, respectively) and in the largest trial, involving 935 women, no benefits were found (12.9% vs 11.3%, respectively).
Nowadays high-risk population with normal cervix is managed by cervical length surveillance and physical activity restriction, as progesterone has not a proved benefit in women at risk because of previous history but normal cervix.
Cervical pessary has not been tested specifically in high risk population. In PECEP study a total number of 42 patients (11% of each group) had at least one previous preterm birth. Authors did not report differences in the risk of preterm birth before 34 weeks in this subgroup. In Nicolaides study, 154 patients had previous birth before 37 weeks: 70 were treated with pessary and 84 with expectant management. The reported risk of birth before 34 weeks was 10.1% and 19.5%, respectively. In spite of the increased risk in expectant group, these differences were not significant (OR 0.47 (0.18-1.21) p= 0.12). In both trials, women included has short cervix.
Even that group of women with previous preterm birth were included in the previous trials, pessary has not been proved in a specific group of population with previous history of preterm birth or uterine-cervical factors. Therefore, there is a lack of information in this topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pessary Group | Experimental | Device: Cervical pessaryA pessary certified is inserted through the vagina with the woman in recumbent position and is placed around the cervix. Correct placement of the pessary is assessed by ultrasound. Patients on the pessary group are specially awarded about adverse symptoms and the need of immediate report in case of pain, bleeding and symptomatic contractions. The pessary is not removed when symptoms of infection occur after pessary insertion, but appropriate treatment is given. The pessary is removed at 37 weeks of pregnancy. Indications for pessary removal before 37 weeks are: active vaginal bleeding, premature labor not responding to tocolysis or severe patient discomfort. |
| Control group | No intervention | –Current management for the follow-up of these women in the PBPC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Singleton pregnancy.
- Age > 18 years old.
- Gestational age between 18.0 -23.6 weeks of gestation.
- Asymptomatic singleton pregnancies, with at least one of the following:
- Able to sign informed consent form.
Key exclusion criteria (7 listed)
- Congenital, chromosomal abnormalities or stillbirth in current pregnancy before randomization.
- Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
- Symptomatic high-risk women or preterm prelabor rupture of membranes (PROM) in the current pregnancy.
- Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
- Pregnant women with an indication to perform a cervical cerclage, prior to study inclusion.
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 pessaryCervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall. | Device | Pessary Group |
Primary outcome
Spontaneous preterm birth before 37 weeks of gestation
Time frame: 3 years
Delivery < 37.0 weeks of gestation (Yes/No)
20 secondary outcomes
Preterm birth 34 weeks
Time frame: 5 months
Preterm birth 28 weeks
Time frame: 5 months
PPROM before 34 weeks
Time frame: 5 months
Threatened preterm labor
Time frame: 5 months
Cervical trauma
Time frame: 5 months
Pessary tolerance
Time frame: 5 months
Infection
Time frame: 5 months
Progesterone co-treatment
Time frame: 5 months
Choriomanionitis
Time frame: 5 months
Maternal mortality or morbidity
Time frame: 5 months
Neonatal birthweight
Time frame: 5 months
Neonatal outcomes APGAR
Time frame: 5 months
Neonatal outcomes umbilical artery pH
Time frame: 5 months
Neonatal outcomes NICU
Time frame: 5 months
Neonatal outcomes for respiratory support
Time frame: 5 months
Neonatal outcomes SDR
Time frame: 5 months
Neonatal outcomes IVH
Time frame: 5 months
Neonatal outcomes NEC
Time frame: 5 months
Neonatal outcomes. Death
Time frame: 5 months
Neonatal outcomes. Sepsis
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 21210482Beta J, Akolekar R, Ventura W, Syngelaki A, Nicolaides KH. Prediction of spontaneous preterm delivery from maternal factors, obstetric history and placental perfusion and function at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):75-83. doi: 10.1002/pd.2662.
- Background: PubMed 20014326Sotiriadis A, Papatheodorou S, Kavvadias A, Makrydimas G. Transvaginal cervical length measurement for prediction of preterm birth in women with threatened preterm labor: a meta-analysis. Ultrasound Obstet Gynecol. 2010 Jan;35(1):54-64. doi: 10.1002/uog.7457.
- Background: PubMed 18432605Celik E, To M, Gajewska K, Smith GC, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Cervical length and obstetric history predict spontaneous preterm birth: development and validation of a model to provide individualized risk assessment. Ultrasound Obstet Gynecol. 2008 May;31(5):549-54. doi: 10.1002/uog.5333.
- Background: PubMed 20708169Owen J, Szychowski JM, Hankins G, Iams JD, Sheffield JS, Perez-Delboy A, Berghella V, Wing DA, Guzman ER; Vaginal Ultrasound Trial Consortium. Does midtrimester cervical length >/=25 mm predict preterm birth in high-risk women? Am J Obstet Gynecol. 2010 Oct;203(4):393.e1-5. doi: 10.1016/j.ajog.2010.06.025. Epub 2010 Aug 12.
- Background: PubMed 24186101Care AG, Sharp AN, Lane S, Roberts D, Watkins L, Alfirevic Z. Predicting preterm birth in women with previous preterm birth and cervical length >/= 25 mm. Ultrasound Obstet Gynecol. 2014 Jun;43(6):681-6. doi: 10.1002/uog.13241.
- Background: PubMed 22284156Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.
- Background: PubMed 21691173Berghella V, Mackeen AD. Cervical length screening with ultrasound-indicated cerclage compared with history-indicated cerclage for prevention of preterm birth: a meta-analysis. Obstet Gynecol. 2011 Jul;118(1):148-155. doi: 10.1097/AOG.0b013e31821fd5b0.
- 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 23728668Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA. Cervical pessary for preventing preterm birth. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007873. doi: 10.1002/14651858.CD007873.pub3.
- 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 22875662Hui SY, Chor CM, Lau TK, Lao TT, Leung TY. Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial. Am J Perinatol. 2013 Apr;30(4):283-8. doi: 10.1055/s-0032-1322550. Epub 2012 Aug 8.
- Background: PubMed 26321037Nicolaides KH, Syngelaki A, Poon LC, de Paco Matallana C, Plasencia W, Molina FS, Picciarelli G, Tul N, Celik E, Lau TK, Conturso R. Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial. Am J Obstet Gynecol. 2016 Jan;214(1):3.e1-9. doi: 10.1016/j.ajog.2015.08.051. Epub 2015 Aug 28.
- Gestation-specific Infant Mortality: 2012Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
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.
Silvia Irene Ferrero Martínez, MD,PhD principal investigator
BCNatal | Hospital Sant Joan de Déu - Hospital Clínic
Montse Palacio Riera, MD,PhD study director
BCNatal | Hospital Clínic- Hospital Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical pessary in people with Preterm Birth, run by Hospital Sant Joan de Deu at 1 site in Spain.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Irene Ferrero Martínez, MD,PhD (+34932532100, sferrero@sjdhospitalbarcelona.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous preterm birth before 37 weeks of gestation (time frame: 3 years). 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 NCT04147117, which also lists 16 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 4 Jun 2020.