The Trial of Pessary After Laser for TTTS (PECEPLASER)

Vall d'Hebron University Hospital (HUVH)

Status: Terminated

Conditions: Premature Birth

Treatments: Device: Arabin Cervical Pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT01334489

PECEP_LASER Trial

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 352 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups

Usual management

No Intervention group

Description:

Usual management of monochorionic pregnancy without the pessary placement

Arabin Cervical Pessary

Other group

Description:

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.

Treatment:

Device: Arabin Cervical Pessary