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The Trial of Pessary After Laser for TTTS (PECEPLASER)

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ClinicalTrials.gov Identifier: NCT01334489
Recruitment Status : Recruiting
First Posted : April 13, 2011
Last Update Posted : March 31, 2017
Sponsor:
Collaborators:
Maternal-Infantil Vall d´Hebron Hospital
Universitaire Ziekenhuizen Leuven
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

April 12, 2011
April 13, 2011
March 31, 2017
December 2012
December 2017   (Final data collection date for primary outcome measure)
Delivery before 32 weeks [ Time Frame: Within the first 15 days after delivery ]
Rate of delivery before 32 weeks
Spontaneous delivery before 34 completed weeks [ Time Frame: Within the first 15 days after delivery ]
Rate of delivery before 34+6 weeks, due to spontaneous preterm labour (the iatrogenous delivery due to maternal or fetal conditions will be excluded).
Complete list of historical versions of study NCT01334489 on ClinicalTrials.gov Archive Site
  • Birth weight [ Time Frame: Within the first 15 days after delivery ]
    Median weight (g) of the newborns at birth.
  • Fetal or neonatal death [ Time Frame: Within the first 15 days after the death ]
    Rate of intrauterine demise or neonatal death during the first 24 hours.
  • Neonatal morbidity [ Time Frame: 30 days after the discharge from the hospital ]
    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 ]
    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 ]
    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 ]
    Rate of delivery before 36+6 weeks
  • Rupture of membranes before 32 weeks [ Time Frame: Within 15 days after delivery ]
    Rupture of amniotic membranes before 31+6 weeks
  • Hospitalisation for threatened preterm labour before 32 weeks [ Time Frame: Within 15 days after delivery ]
    Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks (rate).
  • Time to birth [ Time Frame: Within 15 days after delivery ]
  • Preterm birth before 34 weeks [ Time Frame: Within 15 days after delivery ]
    rate of delivery before 33+6 weeks
  • Preterm birth before 30 weeks [ Time Frame: Within 15 days after delivery ]
    rate of delivery before 29+6 weeks
  • Preterm birth before 28 weeks [ Time Frame: Within 15 days after delivery ]
    rate of delivery before 27+6 weeks
  • Birth weight [ Time Frame: Within the first 15 days after delivery ]
    Median weight (g) of the newborns at birth.
  • Fetal or neonatal death [ Time Frame: Within the first 15 days after the death ]
    Rate of intrauterine demise or neonatal death during the first 24 hours.
  • Neonatal morbidity [ Time Frame: 30 days after the discharge from the hospital ]
    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 ]
    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 ]
    Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).
  • Spontaneous preterm birth before 37 weeks [ Time Frame: Within 15 days after delivery ]
    Rate of delivery before 36+6 weeks due to spontaneous contractions and labour (excluding iatrogenous causes).
  • Spontaneous rupture of membranes before 34 weeks [ Time Frame: Within 15 days after delivery ]
    Rate of spontaneous rupture of amniotic membranes before 33+6 weeks (excluding iatrogenous causes).
  • Hospitalisation for threatened preterm labour before 34 weeks [ Time Frame: Within 15 days after delivery ]
    Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 33+6 weeks (rate).
Not Provided
Not Provided
 
The Trial of Pessary After Laser for TTTS
Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Laser Coagulation: The PECEP Laser Trial
Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.

Monochorionic (MC) twin pregnancies present with a high rate of fetal complications, most of them associated with the placental vascular anastomoses. Fetoscopic laser coagulation (FLC) 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 is 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 FLC remains a big challenge, so new methods to prevent it must be investigated.

Previous studies in singletons 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Premature Birth
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.

  • No Intervention: Usual management
    Usual management of monochorionic pregnancy without the pessary placement
  • Arabin Cervical 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.

    Intervention: Device: Arabin Cervical Pessary

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
352
144
June 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Carlota Rodo, MD 0034-934893072 carlotarodo@gmail.com
Contact: Elena Carreras, PhD 0034-934893072 ecarreras@vhebron.net
Belgium,   Germany,   Spain
France,   United Kingdom
 
NCT01334489
PECEP_LASER Trial
No
Not Provided
Not Provided
Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari Vall d'Hebron Research Institute
  • Maternal-Infantil Vall d´Hebron Hospital
  • Universitaire Ziekenhuizen Leuven
  • Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Elena Carreras, PhD Hospital Vall d'Hebron
Hospital Universitari Vall d'Hebron Research Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP