An interventional study of Arabin Cervical Pessary in Premature Birth, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Terminated at 4 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Prevention
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 352 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Usual management of monochorionic pregnancy without the pessary placement
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.
Delivery before 32 weeks
Rate of delivery before 32 weeks
Time frame: Within the first 15 days after delivery
Birth weight
Median weight (g) of the newborns at birth.
Time frame: Within the first 15 days after delivery
Fetal or neonatal death
Rate of intrauterine demise or neonatal death during the first 24 hours.
Time frame: Within the first 15 days after the death
Neonatal morbidity
Rate of major adverse neonatal outcomes before discharge from the hospital.
Time frame: 30 days after the discharge from the hospital
Significant maternal adverse events
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).
Time frame: Within 15 days after discharge from the hospital
Physical or psychological intolerance to pessary
Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).
Time frame: Within 15 days after discharge from hospital
Preterm birth before 37 weeks
Rate of delivery before 36+6 weeks
Time frame: Within 15 days after delivery
Rupture of membranes before 32 weeks
Rupture of amniotic membranes before 31+6 weeks
Time frame: Within 15 days after delivery
Hospitalisation for threatened preterm labour before 32 weeks
Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks (rate).
Time frame: Within 15 days after delivery
Time to birth
Time frame: Within 15 days after delivery
Preterm birth before 34 weeks
rate of delivery before 33+6 weeks
Time frame: Within 15 days after delivery
Preterm birth before 30 weeks
rate of delivery before 29+6 weeks
Time frame: Within 15 days after delivery
Preterm birth before 28 weeks
rate of delivery before 27+6 weeks
Time frame: Within 15 days after delivery
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute