Use of Pessary in Case of Cervical Insufficiency and Short Cervix

NCT03096691 | Unknown DMC FDA Device

• 1 other identifier: 058
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Labor

Keywords

cervical pessary; preterm labor; Cervical insufficiency

Outcome Measures

Primary Outcomes (1)

• Preterm delivery

  Spontaneous delivery before 34 completed weeks

  Less than 34 weeks gestation

Study Arms (2)

short cervix group

ACTIVE COMPARATOR

cervical pessary in group with first pregnancy or no preterm labor

Device: cervical pessary

group with cervical insufficiency

ACTIVE COMPARATOR

cervical pessary in group with multiple preterm labor

Device: cervical pessary

Interventions

cervical pessary DEVICE

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

Also known as: arabin pessary

group with cervical insufficiency; short cervix group

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Maternity and Children's Hospital

Istanbul, 34718, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 26981934 BACKGROUND

• Goya 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.

  PMID: 22475493 BACKGROUND

• 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.

  PMID: 19796732 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature; Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases

Study Officials

• dilsad herkiloglu, MD

  Zeynep Kamil Maternity and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dilsad herkiloglu, MD

CONTACT

5428423742; dilsadherkiloglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 about the use of disease pessaries and treatment success in preventing premature birth of the pessary will be provided. 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.

Study Record Dates

• First Submitted: March 25, 2017
• First Posted: March 30, 2017
• Study Start: February 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)