Pessary Use for Stress Urinary Incontinence in Pregnancy
NCT ID: NCT04590092
Last Updated: 2022-06-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-02-01
Study Completion Date
2022-09-30
Brief Summary
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When women are pregnant they are more likely to leak urine which can severely affect their quality of life. This problem could be fixed by using a pessary. A pessary is a silicone ring that goes into the vagina which can stop or improve urinary leakage. These devices have been safely used for hundreds of years. However, pessaries has not been studied for urinary leakage in pregnancy. The investigators would like to compare severity of urinary leakage using a number of questionnaires during the last 3 months of pregnancy for women using a pessary versus women without a pessary.
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Detailed Description
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Specific Aims To determine if an incontinence pessary will improve condition-specific quality of life for women with stress urinary incontinence (SUI) in the third trimester of pregnancy and collect pilot data to inform sample size and feasibility for a larger randomized controlled trial.
Background/Significance The prevalence of antenatal urinary incontinence (UI) in nulliparous women is 30-40%; the prevalence increases with multiparity and prior vaginal delivery. Stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) are reported by 37% and 58% of gravidas respectively. Fifty percent of all new UI in pregnancy is SUI. As pregnancy progresses the prevalence of SUI increases from 8.3% to 36.9% in the third trimester. The frequency, volume and severity of the UI worsens with increasing gestational age, resulting in increasingly profound effects on women's daily life. These concerns are often underreported and under recognized by clinicians. SUI in pregnancy is currently managed with pelvic floor exercises, associated with incomplete symptom relief, suboptimal patient adherence and limited evidence.
Incontinence pessaries can be a ring or a dish with an incontinence knob. These pessaries decrease UI by providing compression and support to the urethra. Up to 63% of non-pregnant women fitted with an incontinence pessary are satisfied with the treatment at 3 months; after one year of use 50-59% of women remain satisfied and one third have "no bothersome SUI symptoms". Pessaries are a low risk and effective option to manage UI. The use of incontinence pessaries is supported for the treatment of SUI in non-pregnant women by the Society of Obstetrics and Gynaecology of Canada.
Pessaries are safe in pregnancy and have been reported for the management of cervical insufficiency, pelvic organ prolapse, and incarcerated uterus. While some believe pregnant women are ideal candidates for incontinence pessaries, supporting evidence is required. There are currently no obstetrical guidelines supporting pessary use for incontinence in pregnancy despite pessaries being a low risk treatment option; clinicians are currently limited to offering pelvic floor exercises for antepartum urinary incontinence. Pessaries are a safe and effective management option for UI in pregnancy and they can be managed independently by the patient.
Stress urinary incontinence represents a common concern in pregnancy and lacks evidence-based treatment options. In this pilot trial, the investigators propose to quantify the effect of incontinence pessaries on condition-specific quality of life and SUI symptoms in pregnant women, and to determine rate of successful pessary fitting, treatment acceptability, sexual function, patterns of adherence, discontinuation rate, adverse events and global impression of improvement. Our trial will provide important evidence for a much-needed larger clinical trial aiming to investigate incontinence pessaries as a treatment option for SUI in pregnancy.
Methodology
Design: Pilot randomized controlled trial
Sample Size: The effect size of a pessary for the treatment of SUI in pregnancy is unknown. A convenience sample of 60 women will be recruited, with 30 women randomized to the intervention arm (incontinence pessary) and 30 to the control arm (usual care).
Primary objective of pilot trial: To evaluate the effect size of an antepartum incontinence pessary on the condition-specific quality of life of women with SUI in pregnancy, in order to inform sample size calculations for a larger randomized controlled trial.
Secondary objectives of pilot trial: To evaluate feasibility and methodological barriers for a future randomized controlled trial.
Experimental Design:
The investigators propose a prospective randomized controlled pilot trial of women with bothersome SUI in the third trimester of a healthy singleton pregnancy. A convenience sample of 30 women per arm will be recruited from obstetrical clinics. Women between 26- 28weeks gestational age who answer yes to the screening question "Do you have bothersome urinary leakage when you cough, sneeze or walk during this pregnancy?" will be invited to participate in our proposed study by their primary maternity provider. The study coordinator will screen potential participants by phone to ensure they meet out inclusion and exclusion criteria and have a minimal Pelvic Floor Distress Inventory (PFDI-20) score of 25 for the UDI-6 section, to ensure bother from SUI. Informed consent will be obtained. Following recruitment, a baseline assessment (PFDI, Pelvic Floor Inventory Questionnaire (PFIQ), Female Sexual Function Inventory (FSFI) and a bladder diary) and collection of demographic data will be completed. These questionnaires will be emailed to participants. Participants will then be randomized to the control or treatment group. The control group will continue with standard obstetrical care while an incontinence pessary will be fitted for women in the treatment group by an experienced nurse incontinence advisor at our pessary clinic.
Following randomization all participants will be screened every two weeks from 28 weeks gestational age with the interim questionnaire. They will receive a biweekly phone call from either the nurse continence advisor or the urogynecology fellow. For the treatment arm this call will include their obstetric health, pessary tolerance and any adverse events. Women in the control group will be asked the interim obstetrical questions only. This will continue until delivery, pessary discontinuation, or 36 weeks gestational age at which point the patient will be discharged from the study. An exit interview will be completed and will consist of a final review of the biweekly questions, the questionnaires (PFDI, PFIQ, FSFI and a bladder diary), and the acceptability questionnaire for those participants using a pessary. Participants using a pessary will be asked to remove it at the end of the study. The investigators will also collect data on study feasibility including recruitment rate, methodological barriers, and follow up.
Intervention:
After deemed appropriate for recruitment, participants will be randomized to the control or intervention arm. Both groups will continue to receive routine antenatal care and will receive a handout on pelvic floor exercises in pregnancy. Women in the intervention arm will be fitted with an incontinence ring pessary by an incontinence nurse experienced in pessary fitting. They will be taught pessary maintenance and encouraged to remove and insert the pessary independently. Participants will receive a handout on pessary use, risks and obstetrical indications to remove the pessary.
Data Analysis:
Descriptive statistics on demographic characteristics will be reported. Condition-specific quality of life and distress scores will be compared between control and intervention arms using regression analysis adjusted for baseline score. Depending on the distribution of the data, linear, generalized linear or quantile regression will be used. The main analysis will be an intention-to-treat analysis which will include all women followed to the end of study, with sensitivity analysis being a per protocol analysis which excluded women who discontinued pessary prematurely. Effect size and variance will be calculated and used for future sample size calculations. Pessary fitting success rate, discontinuation rates, and adverse events will be continuously monitored. The investigators aim to recruit 2-3 women per week with a drop-out rate under 20%.
Background/Significance The prevalence of antenatal urinary incontinence (UI) in nulliparous women is 30-40%; the prevalence increases with multiparity and prior vaginal delivery. Stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) are reported by 37% and 58% of gravidas respectively. Fifty percent of all new UI in pregnancy is SUI. As pregnancy progresses the prevalence of SUI increases from 8.3% to 36.9% in the third trimester. The frequency, volume and severity of the UI worsens with increasing gestational age, resulting in increasingly profound effects on women's daily life. These concerns are often underreported and under recognized by clinicians. SUI in pregnancy is currently managed with pelvic floor exercises, associated with incomplete symptom relief, suboptimal patient adherence and limited evidence.
Incontinence pessaries can be a ring or a dish with an incontinence knob. These pessaries decrease UI by providing compression and support to the urethra. Up to 63% of non-pregnant women fitted with an incontinence pessary are satisfied with the treatment at 3 months; after one year of use 50-59% of women remain satisfied and one third have "no bothersome SUI symptoms". Pessaries are a low risk and effective option to manage UI. The use of incontinence pessaries is supported for the treatment of SUI in non-pregnant women by the Society of Obstetrics and Gynaecology of Canada.
Pessaries are safe in pregnancy and have been reported for the management of cervical insufficiency, pelvic organ prolapse, and incarcerated uterus. While some believe pregnant women are ideal candidates for incontinence pessaries, supporting evidence is required. There are currently no obstetrical guidelines supporting pessary use for incontinence in pregnancy despite pessaries being a low risk treatment option; clinicians are currently limited to offering pelvic floor exercises for antepartum urinary incontinence. Pessaries are a safe and effective management option for UI in pregnancy and they can be managed independently by the patient.
Stress urinary incontinence represents a common concern in pregnancy and lacks evidence-based treatment options. In this pilot trial, the investigators propose to quantify the effect of incontinence pessaries on condition-specific quality of life and SUI symptoms in pregnant women, and to determine rate of successful pessary fitting, treatment acceptability, sexual function, patterns of adherence, discontinuation rate, adverse events and global impression of improvement. Our trial will provide important evidence for a much-needed larger clinical trial aiming to investigate incontinence pessaries as a treatment option for SUI in pregnancy.
Methodology
Design: Pilot randomized controlled trial
Sample Size: The effect size of a pessary for the treatment of SUI in pregnancy is unknown. A convenience sample of 60 women will be recruited, with 30 women randomized to the intervention arm (incontinence pessary) and 30 to the control arm (usual care).
Primary objective of pilot trial: To evaluate the effect size of an antepartum incontinence pessary on the condition-specific quality of life of women with SUI in pregnancy, in order to inform sample size calculations for a larger randomized controlled trial.
Secondary objectives of pilot trial: To evaluate feasibility and methodological barriers for a future randomized controlled trial.
Experimental Design:
The investigators propose a prospective randomized controlled pilot trial of women with bothersome SUI in the third trimester of a healthy singleton pregnancy. A convenience sample of 30 women per arm will be recruited from obstetrical clinics. Women between 26- 28weeks gestational age who answer yes to the screening question "Do you have bothersome urinary leakage when you cough, sneeze or walk during this pregnancy?" will be invited to participate in our proposed study by their primary maternity provider. The study coordinator will screen potential participants by phone to ensure they meet out inclusion and exclusion criteria and have a minimal Pelvic Floor Distress Inventory (PFDI-20) score of 25 for the UDI-6 section, to ensure bother from SUI. Informed consent will be obtained. Following recruitment, a baseline assessment (PFDI, Pelvic Floor Inventory Questionnaire (PFIQ), Female Sexual Function Inventory (FSFI) and a bladder diary) and collection of demographic data will be completed. These questionnaires will be emailed to participants. Participants will then be randomized to the control or treatment group. The control group will continue with standard obstetrical care while an incontinence pessary will be fitted for women in the treatment group by an experienced nurse incontinence advisor at our pessary clinic.
Following randomization all participants will be screened every two weeks from 28 weeks gestational age with the interim questionnaire. They will receive a biweekly phone call from either the nurse continence advisor or the urogynecology fellow. For the treatment arm this call will include their obstetric health, pessary tolerance and any adverse events. Women in the control group will be asked the interim obstetrical questions only. This will continue until delivery, pessary discontinuation, or 36 weeks gestational age at which point the patient will be discharged from the study. An exit interview will be completed and will consist of a final review of the biweekly questions, the questionnaires (PFDI, PFIQ, FSFI and a bladder diary), and the acceptability questionnaire for those participants using a pessary. Participants using a pessary will be asked to remove it at the end of the study. The investigators will also collect data on study feasibility including recruitment rate, methodological barriers, and follow up.
Intervention:
After deemed appropriate for recruitment, participants will be randomized to the control or intervention arm. Both groups will continue to receive routine antenatal care and will receive a handout on pelvic floor exercises in pregnancy. Women in the intervention arm will be fitted with an incontinence ring pessary by an incontinence nurse experienced in pessary fitting. They will be taught pessary maintenance and encouraged to remove and insert the pessary independently. Participants will receive a handout on pessary use, risks and obstetrical indications to remove the pessary.
Data Analysis:
Descriptive statistics on demographic characteristics will be reported. Condition-specific quality of life and distress scores will be compared between control and intervention arms using regression analysis adjusted for baseline score. Depending on the distribution of the data, linear, generalized linear or quantile regression will be used. The main analysis will be an intention-to-treat analysis which will include all women followed to the end of study, with sensitivity analysis being a per protocol analysis which excluded women who discontinued pessary prematurely. Effect size and variance will be calculated and used for future sample size calculations. Pessary fitting success rate, discontinuation rates, and adverse events will be continuously monitored. The investigators aim to recruit 2-3 women per week with a drop-out rate under 20%.
Conditions
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Stress Urinary Incontinence
Pregnancy Related
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Control
Study Participants who do not receive a pessary. This group will be given an information pamphlet on pelvic floor (Kegel) exercises in pregnancy and will continue to have standard antenatal care with their maternity provider.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Pessary
Study Participants who are fitted with a pessary for urinary incontinence. This group will be given an information pamphlet on pelvic floor (Kegel) exercises in pregnancy and pessary use in pregnancy. They will continue to have standard antenatal care with their maternity provider.
Group Type
EXPERIMENTAL
Cooper Surgical Ring Pessary with Incontinence Knob
Intervention Type
DEVICE
A pessary is a silicone ring with a knob that in inserted into the vagina to treat urinary incontinence by providing urethral support.
Interventions
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Cooper Surgical Ring Pessary with Incontinence Knob
A pessary is a silicone ring with a knob that in inserted into the vagina to treat urinary incontinence by providing urethral support.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* English speaking women over 19 years old
* Nulliparous and multiparous women over 26 weeks gestational age with a healthy singleton pregnancy
* Bothersome symptoms of stress urinary incontinence or stress-predominant mixed urinary incontinence with a minimal PDFI score of 25 on the UDI-6 section.
* Nulliparous and multiparous women over 26 weeks gestational age with a healthy singleton pregnancy
* Bothersome symptoms of stress urinary incontinence or stress-predominant mixed urinary incontinence with a minimal PDFI score of 25 on the UDI-6 section.
Exclusion Criteria
* Stage 3 or greater pelvic organ prolapse
* Contraindication to pessary use (known pelvic infection, vaginal or cervical lesions)
* Previous surgery for urinary incontinence
* History of preterm delivery and current threatened preterm labour
* Premature preterm rupture of membranes
* Short cervix
* Hospitalization in the current pregnancy
* Antepartum hemorrhage
* Fetal anomaly
* Prior trial of pessary or current pessary use
* Vulvodynia
* Contraindication to pessary use (known pelvic infection, vaginal or cervical lesions)
* Previous surgery for urinary incontinence
* History of preterm delivery and current threatened preterm labour
* Premature preterm rupture of membranes
* Short cervix
* Hospitalization in the current pregnancy
* Antepartum hemorrhage
* Fetal anomaly
* Prior trial of pessary or current pessary use
* Vulvodynia
Minimum Eligible Age
19 Years
Maximum Eligible Age
60 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University of British Columbia
OTHER
Sponsor Role
lead
Responsible Party
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Catherine Smith
Clinical Administrator, Advanced Training in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) program
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Catherine Smith, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Providence Health Care - St Paul's Hospital
Vancouver, British Columbia, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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Nikki Koenig
Role: primary
References
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Daly D, Clarke M, Begley C. Urinary incontinence in nulliparous women before and during pregnancy: prevalence, incidence, type, and risk factors. Int Urogynecol J. 2018 Mar;29(3):353-362. doi: 10.1007/s00192-018-3554-1. Epub 2018 Jan 23.
Reference Type
BACKGROUND
Balik G, Guven ES, Tekin YB, Senturk S, Kagitci M, Ustuner I, Mete Ural U, Sahin FK. Lower Urinary Tract Symptoms and Urinary Incontinence During Pregnancy. Low Urin Tract Symptoms. 2016 May;8(2):120-4. doi: 10.1111/luts.12082. Epub 2014 Dec 11.
Reference Type
BACKGROUND
Gyhagen M, Akervall S, Molin M, Milsom I. The effect of childbirth on urinary incontinence: a matched cohort study in women aged 40-64 years. Am J Obstet Gynecol. 2019 Oct;221(4):322.e1-322.e17. doi: 10.1016/j.ajog.2019.05.022. Epub 2019 May 21.
Reference Type
BACKGROUND
Brown SJ, Donath S, MacArthur C, McDonald EA, Krastev AH. Urinary incontinence in nulliparous women before and during pregnancy: prevalence, incidence, and associated risk factors. Int Urogynecol J. 2010 Feb;21(2):193-202. doi: 10.1007/s00192-009-1011-x. Epub 2009 Oct 16.
Reference Type
BACKGROUND
Solans-Domenech M, Sanchez E, Espuna-Pons M; Pelvic Floor Research Group (Grup de Recerca del Sol Pelvia; GRESP). Urinary and anal incontinence during pregnancy and postpartum: incidence, severity, and risk factors. Obstet Gynecol. 2010 Mar;115(3):618-628. doi: 10.1097/AOG.0b013e3181d04dff.
Reference Type
BACKGROUND
Robert M, Schulz JA, Harvey MA; UROGYNAECOLOGY COMMITTEE. RETIRED: Technical update on pessary use. J Obstet Gynaecol Can. 2013 Jul;35(7):664-674. doi: 10.1016/S1701-2163(15)30888-4.
Reference Type
BACKGROUND
Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609-617. doi: 10.1097/AOG.0b013e3181d055d4.
Reference Type
BACKGROUND
Farrell SA, Singh B, Aldakhil L. Continence pessaries in the management of urinary incontinence in women. J Obstet Gynaecol Can. 2004 Feb;26(2):113-7. doi: 10.1016/s1701-2163(16)30486-8.
Reference Type
BACKGROUND
Geoffrion R, Zhang T, Lee T, Cundiff GW. Clinical characteristics associated with unsuccessful pessary fitting outcomes. Female Pelvic Med Reconstr Surg. 2013 Nov-Dec;19(6):339-45. doi: 10.1097/SPV.0b013e3182a26174.
Reference Type
BACKGROUND
Vasconcelos CTM, Silva Gomes ML, Ribeiro GL, Oria MOB, Geoffrion R, Vasconcelos Neto JA. Women and healthcare providers' knowledge, attitudes and practice related to pessaries for pelvic organ prolapse: A Systematic review. Eur J Obstet Gynecol Reprod Biol. 2020 Apr;247:132-142. doi: 10.1016/j.ejogrb.2020.02.016. Epub 2020 Feb 14.
Reference Type
BACKGROUND
Saccone G, Ciardulli A, Xodo S, Dugoff L, Ludmir J, Pagani G, Visentin S, Gizzo S, Volpe N, Maruotti GM, Rizzo G, Martinelli P, Berghella V. Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta-analysis. J Ultrasound Med. 2017 Aug;36(8):1535-1543. doi: 10.7863/ultra.16.08054. Epub 2017 Apr 11.
Reference Type
BACKGROUND
Jarde A, Lutsiv O, Beyene J, McDonald SD. Vaginal progesterone, oral progesterone, 17-OHPC, cerclage, and pessary for preventing preterm birth in at-risk singleton pregnancies: an updated systematic review and network meta-analysis. BJOG. 2019 Apr;126(5):556-567. doi: 10.1111/1471-0528.15566. Epub 2018 Dec 29.
Reference Type
BACKGROUND
Zeng C, Yang F, Wu C, Zhu J, Guan X, Liu J. Uterine Prolapse in Pregnancy: Two Cases Report and Literature Review. Case Rep Obstet Gynecol. 2018 Oct 22;2018:1805153. doi: 10.1155/2018/1805153. eCollection 2018.
Reference Type
BACKGROUND
De Vita D, Giordano S. Two successful natural pregnancies in a patient with severe uterine prolapse: A case report. J Med Case Rep. 2011 Sep 14;5:459. doi: 10.1186/1752-1947-5-459.
Reference Type
BACKGROUND
Rusavy Z, Bombieri L, Freeman RM. Procidentia in pregnancy: a systematic review and recommendations for practice. Int Urogynecol J. 2015 Aug;26(8):1103-9. doi: 10.1007/s00192-014-2595-3. Epub 2015 Jan 20.
Reference Type
BACKGROUND
Yohannes P, Schaefer J. Urinary retention during the second trimester of pregnancy: a rare cause. Urology. 2002 Jun;59(6):946. doi: 10.1016/s0090-4295(02)01551-0.
Reference Type
BACKGROUND
Viera AJ, Larkins-Pettigrew M. Practical use of the pessary. Am Fam Physician. 2000 May 1;61(9):2719-26, 2729.
Reference Type
BACKGROUND
Al-Shaikh G, Syed S, Osman S, Bogis A, Al-Badr A. Pessary use in stress urinary incontinence: a review of advantages, complications, patient satisfaction, and quality of life. Int J Womens Health. 2018 Apr 17;10:195-201. doi: 10.2147/IJWH.S152616. eCollection 2018.
Reference Type
BACKGROUND
Other Identifiers
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H20-02900
Identifier Type: -
Identifier Source: org_study_id
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