Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Preterm Labor Clinical Trial

Official title:

Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096691
• Other study ID #: 058
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2017
• Last updated: March 29, 2017
• Start date: February 1, 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: March 2017
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: dilsad herkiloglu, MD
• Phone: 5428423742
• Email: dilsadherkiloglu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prematurity is the most important cause of obstetric morbidity and mortality. Health centers and obstetricians are trying to reduce the preterm birth rate by taking into account the permanent effects of premature birth on human life in the early and long term.

The most effective solution of preterm delivery is to determine the patients entering the risk group and to prevent preterm labor by putting the correct diagnosis at the right time. Recently, there have been studies on the efficacy of pessary practice in preventing preterm birth, but with the positive results of these studies, there has been hope for early birth prevention as well as other treatments.

The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.

Description:

The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.

100 pregnant women with a preterm delivery history and / or a cervical length of less than 25 mm will be included among the pregnancies between 16 and 24 weeks of gestation referred to obstetric and perinatology clinics. Information will be given about the success of treatment in the prevention of early birth of the pessary and the use of the disease pessary. Urine culture and cervical culture samples will be taken from both groups of patients. In the presence of infection, the patient's treatment will be planned and out of work. If no infection is detected and the patient agrees to use the pessary, the pessary will be used to prevent premature birth.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients with a cervical length of 25 mm> and a preterm labor history in the previous pregnancy

Exclusion Criteria:

• Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labor
• Uterine Cervical Incompetence

Intervention

Device:
• cervical pessary
Silicone rings known as arabin pessary are used to support the cervix in women with a sonographic short cervix.

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Maternity and Children's Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Dharan VB, Ludmir J. Alternative treatment for a short cervix: the cervical pessary. Semin Perinatol. 2009 Oct;33(5):338-42. doi: 10.1053/j.semperi.2009.06.008. — View Citation

Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, Juan M, Rodríguez A, Muñoz B, Santacruz B, Bello-Muñoz 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. Erratum in: Lancet. 2012 May 12;379(9828):1790. — View Citation

Nicolaides KH, Syngelaki A, Poon LC, Picciarelli G, Tul N, Zamprakou A, Skyfta E, Parra-Cordero M, Palma-Dias R, Rodriguez Calvo J. A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth. N Engl J Med. 2016 Mar 17;374(11):1044-52. doi: 10.1056/NEJMoa1511014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm delivery	Spontaneous delivery before 34 completed weeks	Less than 34 weeks gestation