Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Selective Laser Coagulation: The PECEP Laser Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Maternal-Infantil Vall d´Hebron Hospital
Sponsor:
Information provided by (Responsible Party):
carlota rodo, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:
NCT01334489
First received: April 12, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by selective fetoscopic laser coagulation (SFLC) decreases the spontaneous preterm birth rate.


Condition Intervention Phase
Premature Birth
Device: Arabin Cervical Pessary
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Selective Laser Coagulation: The PECEP Laser Trial

Resource links provided by NLM:


Further study details as provided by Maternal-Infantil Vall d´Hebron Hospital:

Primary Outcome Measures:
  • Delivery before 32 weeks [ Time Frame: Within the first 15 days after delivery ] [ Designated as safety issue: No ]
    Rate of delivery before 32 weeks


Secondary Outcome Measures:
  • Birth weight [ Time Frame: Within the first 15 days after delivery ] [ Designated as safety issue: No ]
    Median weight (g) of the newborns at birth.

  • Fetal or neonatal death [ Time Frame: Within the first 15 days after the death ] [ Designated as safety issue: No ]
    Rate of intrauterine demise or neonatal death during the first 24 hours.

  • Neonatal morbidity [ Time Frame: 30 days after the discharge from the hospital ] [ Designated as safety issue: No ]
    Rate of major adverse neonatal outcomes before discharge from the hospital.

  • Significant maternal adverse events [ Time Frame: Within 15 days after discharge from the hospital ] [ Designated as safety issue: No ]
    Rate of heavy bleeding (bleeding that requires a medical intervention), cervical tear (cervical rupture due to the pessary placement), and/or uterine rupture (rupture of the uterus due to contractions or surgery).

  • Physical or psychological intolerance to pessary [ Time Frame: Within 15 days after discharge from hospital ] [ Designated as safety issue: No ]
    Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).

  • Preterm birth before 37 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]
    Rate of delivery before 36+6 weeks

  • Rupture of membranes before 34 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]
    Rupture of amniotic membranes before 33+6 weeks

  • Hospitalisation for threatened preterm labour before 34 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]
    Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 33+6 weeks (rate).


Estimated Enrollment: 352
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual management
Usual management of monochorionic pregnancy without the pessary placement
Experimental: Pessary

The pessary will be inserted 24 hours after fetal surgery in the exploration room. This procedure does not need anaesthesia and it does not need to be done in a surgery room. During the following explorations the correct placement of the pessary is assessed, and if it does not, it can be easily adjusted.

The pessary will be removed at 37 weeks of gestation, or before if any unexpected event occurs.

Device: Arabin Cervical Pessary

The Arabin cervical pessary, which is CE-certified for preventing SPB (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC).

It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain.


Detailed Description:

Monochorionic (MC) twin pregnancies present a high rate of fetal complications, most of them associated with vascular anastomosis observed in the placenta. Fetoscopic selective laser coagulation (FSLC) is a surgical technique that allows minimally invasive access into the uterus and has emerged as a useful tool in the management of the most common and severe of these complications, twin to twin transfusion syndrome (TTTS). Even though, preterm birth remains a common cause of adverse outcome because TTTS is associated with a 29 % risk of delivering before 28 weeks.

A short cervical length (CL), defined as a CL ≤ 25 mm, detected by transvaginal ultrasound has been defined as an independent risk factor for preterm birth in twin pregnancies but no effective treatment has been described to prevent it.

Although is usually accepted that in twin pregnancies cerclage may increase the risk of preterm birth, Salomon and co-workers, found that in cases of TTTS with a CL below the 5th percentile (15 mm) at the time of surgery, performing an emergency cerclage prolonged the pregnancy and allow for better outcome, But still preterm birth after FSLC remains a big challenge, so new methods of preventing it must be investigated.

Previous studies in singleton and twins have shown that the use of cervical pessary significantly reduces the frequency of birth before 32 weeks and prolongs pregnancy. The advantage of using cervical pessary is that it is less invasive than cerclage and can be removed easily. That's the reason why pessaries could be considered an alternative, non invasive option to prevent preterm birth in cases of twin to twin transfusion syndrome (TTTS) treated by laser surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery
  • Less than 26 weeks
  • Minimal age of 18 years
  • Informed consent signature

Exclusion Criteria:

  • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • Cerclage prior to randomisation
  • Uterine malformation
  • Placenta previa
  • Active vaginal bleeding at the moment of randomization
  • Spontaneous rupture of membranes at the time of randomization
  • Death of both twins after the surgery
  • Monochorionic-monoamniotic twin pregnancy
  • Silicone allergy
  • Current participation in other RCT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334489

Contacts
Contact: Carlota Rodo, MD 0034-934893072 carlotarodo@gmail.com
Contact: Elena Carreras, PhD 0034-934893072 ecarreras@vhebron.net

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Carlota Rodo, MD    0034-934893072    carlotarodo@gmail.com   
Contact: Arevalo Silvia, MD    0034-934893072    silviaarevalomartinez@gmail.com   
Principal Investigator: Elena Carreras, PhD         
Principal Investigator: Carlota Rodo, MD         
Sub-Investigator: Silvia Arevalo, MD         
Sub-Investigator: Maria M Goya, MD         
Sub-Investigator: Anna Maroto, MD         
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
Investigators
Principal Investigator: Elena Carreras, PhD Hospital Universitari Vall d'Hebron
  More Information

Additional Information:
Publications:

Responsible Party: carlota rodo, MD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT01334489     History of Changes
Other Study ID Numbers: PECEP_LASER Trial
Study First Received: April 12, 2011
Last Updated: July 8, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Maternal-Infantil Vall d´Hebron Hospital:
Monochorionic pregnancy
Twin to twin transfusion syndrome
Cervical pessary
Cervical length

Additional relevant MeSH terms:
Fetofetal Transfusion
Premature Birth
Syndrome
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Disease
Pathologic Processes
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 19, 2014