Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial (ENCIRCLE)
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|ClinicalTrials.gov Identifier: NCT03818867|
Recruitment Status : Unknown
Verified January 2019 by St George's, University of London.
Recruitment status was: Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Twin pregnancies are at an increased risk of early delivery. One of the reasons for this may be due to a weakened neck of the womb (cervix). There are 2 main ways to manage a weakened cervix in pregnancy. One option is to do nothing (conservative approach). The other is to strengthen the cervix with a stitch (cerclage) to provide extra support. There is no good quality convincing evidence to suggest which of these has better outcomes for mum and babies in twin pregnancies. This trial aims to determine whether securing the weakened cervix with a cerclage will help to prolong the pregnancy and prevent early delivery. Babies who are born early experience multiple complications including lung, brain and learning difficulties. Therefore, the study will also aim to determine whether prolonging the pregnancy by inserting the cerclage reduces the number of babies affected by these problems. In order to carry out a fair study we aim to perform what is known as a randomised controlled trial. We will include in the trial two major groups: (1) women pregnant with twins, who present with a weakened cervix and no signs of infection between 14 and 26 weeks of pregnancy. This will be diagnosed on an internal examination or ultrasound scan, and (2) women pregnant with identical twins complicated by twin-to-twin transfusion syndrome (TTTS) treated by Laser surgery between 16 and 26 weeks in whom a short cervix (<15mm) is identified. TTTS is rare but potentially devastating condition which occurs in about 10-15% of identical twin pregnancies. If left untreated, 80-90% of these babies will die. Overall, best first-line treatment of TTTS is laser surgery. Cervical length is a strong predictor of preterm delivery in these pregnancies.
Participants will be allocated randomly into the intervention (cerclage) or control (conservative) group. The procedure to insert the cerclage will be performed under an anaesthetic to minimise discomfort and you will be admitted for 2-3 days following the operation to ensure there are no complications or signs of labour. Women in both groups will be followed up in the same manner until they deliver and the pregnancy outcomes will be compared between the 2 groups to determine which management option is best.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth Twin Pregnancy With Antenatal Problem Twin to Twin Transfusion Syndrome||Procedure: Insertion of cervical cerclage||Not Applicable|
The study hypothesis is that the placement of an emergency cervical cerclage prolongs the pregnancy in (1) twin pregnancies with a dilated internal cervical os between 14+0 and 26+0 weeks, and (2) in monochorionic twin pregnancies complicated by TTTS treated by Laser surgery between 16+0 and 26+0 weeks' gestation in whom a short cervix (<15mm) is identified.
Study Design: Randomised controlled trial
- Twin pregnancies between 14 - 26 weeks' gestation presenting with an open cervix
- Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome (TTTS) treated by Laser surgery between 16+0 and 26+0 weeks' gestation in whom a short cervix (<15mm) is identified
The primary outcome is time to delivery (from randomisation to birth). Secondary outcomes include gestation at delivery, preterm birth before 28, 32 and 34 weeks' gestation, birthweight, stillbirth, neonatal death, survival to discharge, days of admission to the neonatal intensive care unit, composite outcome of stillbirth, neonatal death, intraventricular haemorrhage, periventricular leukomalacia, respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising entercolitis, proven neonatal sepsis, or the need for ventilation, days of maternal admission for preterm labour and maternal morbidity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Title: Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Cerclage arm
Pregnancies which had cervical cerclage inserted.
Procedure: Insertion of cervical cerclage
insertion of a stitch around the neck of the womb in order to provide extra support.
Other Name: cervical stitch
No Intervention: No-cerclage arm
Pregnancies which did not have cervical cerclage inserted.
- Time to delivery (from randomisation to birth). [ Time Frame: 2 weeks after expected date of birth ]Time between randomisation and delivery in days
- Gestation at delivery [ Time Frame: 2 weeks after expected date of birth ]gestational age at delivery in weeks
- Preterm birth before 28, 32 and 34 weeks' gestation [ Time Frame: 2 weeks after expected date of birth ]the proportion of women giving birth before 28, 32 and 34 weeks
- Birthweight [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]birth weight in grams
- Stillbirth [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]death of the fetus (after 24 weeks) and before birth
- Neonatal death [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]the death of a baby within the first 28 days of life
- Survival to discharge [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]the proportion of the babies surviving until discharge from the hospital after birth
- Days of admission to the neonatal intensive care unit [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]Number of days the baby was admitted in the neonatal intensive care unit
- Composite outcome [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]An outcome which includes any of these outcomes (stillbirth, neonatal death, intraventricular haemorrhage, periventricular leukomalacia, respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising entercolitis, proven neonatal sepsis, or the need for ventilation)
- Days of maternal admission for preterm labour [ Time Frame: 2 weeks after expected date of birth ]Number of days the mother was admitted to the hospital because of preterm labour
- Maternal morbidity (deﬁned as thromboembolic complications, chorioamnionitis, urinary tract infection treated with antibiotics, pneumonia, endometritis, eclampsia, HELLP syndrome, death, or any other significant morbidity) [ Time Frame: 2 weeks after expected date of birth ]complications to the mother related to preterm labour or the insertion of the stitch
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818867
|Contact: Asma Khalilemail@example.com|
|Contact: Rosemary Townsendfirstname.lastname@example.org|
|Principal Investigator:||Asma Khalil||St George's NHS Healthcare Trust|