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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03096691
Other study ID # 058
Secondary ID
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
Health authority
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

Study Design


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
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