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Status unknownNCT03096691Updated Mar 31, 2017

Use of Pessary in Case of Cervical Insufficiency and Short Cervix

An interventional study of cervical pessary in Preterm Labor, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 17 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-31.

Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2016, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
17 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Preterm Labor

Keywords

  • cervical pessary
  • preterm labor
  • Cervical insufficiency
03

In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

This study's planned enrollment of 2 is below the median of 110 across 155 interventional studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (estimated)

Study arms

  • Active comparator
    short cervix group

    cervical pessary in group with first pregnancy or no preterm labor

    Device: cervical pessary

  • Active comparator
    group with cervical insufficiency

    cervical pessary in group with multiple preterm labor

    Device: cervical pessary

Interventions

  • Devicecervical pessary

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

    Also known as: arabin pessary

06

What researchers measure

Primary outcomes

  1. Preterm delivery

    Spontaneous delivery before 34 completed weeks

    Time frame: Less than 34 weeks gestation

07

Study locations

1 of 1 sites recruiting
  • Zeynep Kamil Maternity and Children's Hospital
    Istanbul, 34718, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26981934 ↗
  • 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. Erratum In: Lancet. 2012 May 12;379(9828):1790. PubMed 22475493 ↗
  • 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. PubMed 19796732 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03096691
Lead sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Responsible party
Dilsad Herkiloglu (Principal Investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital) — Principal investigator
First posted
Mar 30, 2017
Start date
Feb 1, 2016
Primary completion
Mar 30, 2017 (estimated)
Completion
Mar 30, 2017 (estimated)
Last update
Mar 31, 2017

Study contacts

dilsad herkiloglu, MD
Contact
dilsadherkiloglu@hotmail.com
5428423742
dilsad herkiloglu, MD
principal investigator · Zeynep Kamil Maternity and Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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