Preterm Birth Clinical Trial
— ENCIRCLEOfficial title:
Study Title: Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial
NCT number | NCT03818867 |
Other study ID # | 17.004 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2017 |
Est. completion date | December 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.
Status | Recruiting |
Enrollment | 31 |
Est. completion date | December 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Twin pregnancies presenting with an open cervix between 14 and 26 weeks of gestation, OR - 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. - Age >18 years - Informed consent Exclusion Criteria: - Cervical dilatation =5cm - Amniotic membranes prolapsed beyond external os into the vagina, unable to visualise cervical tissue - Preterm premature rupture of the membranes (PPROM) at the time of diagnosis of dilated cervix - Major fetal malformations unrelated to TTTS - Intrauterine death of one or both fetuses - Symptoms or signs of threatened imminent delivery, e.g. painful regular uterine contractions, active vaginal bleeding, history of ruptured membranes - Suspected chorioamnionitis [based on maternal uterine tenderness, a temperature of 38°C or greater, significant leucocytosis (>15,000 x 106/L) or elevated C-reactive protein (>15 mg/L), or maternal tachycardia]. - Placenta praevia - Monochorionic monoamniotic twin pregnancies - Prophylactic cervical cerclage - Women who are not able to give valid consent, e.g. unconscious or severely ill - Mental health disorder which impairs the ability to give fully informed consent - Women under the age of 18 years - Higher order multiple pregnancies |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to delivery (from randomisation to birth). | Time between randomisation and delivery in days | 2 weeks after expected date of birth | |
Secondary | Gestation at delivery | gestational age at delivery in weeks | 2 weeks after expected date of birth | |
Secondary | Preterm birth before 28, 32 and 34 weeks' gestation | the proportion of women giving birth before 28, 32 and 34 weeks | 2 weeks after expected date of birth | |
Secondary | Birthweight | birth weight in grams | 42 days (28 days neonatal period+2 weeks postdates) | |
Secondary | Stillbirth | death of the fetus (after 24 weeks) and before birth | 42 days (28 days neonatal period+2 weeks postdates) | |
Secondary | Neonatal death | the death of a baby within the first 28 days of life | 42 days (28 days neonatal period+2 weeks postdates) | |
Secondary | Survival to discharge | the proportion of the babies surviving until discharge from the hospital after birth | 42 days (28 days neonatal period+2 weeks postdates) | |
Secondary | Days of admission to the neonatal intensive care unit | Number of days the baby was admitted in the neonatal intensive care unit | 42 days (28 days neonatal period+2 weeks postdates) | |
Secondary | Composite outcome | 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) | 42 days (28 days neonatal period+2 weeks postdates) | |
Secondary | Days of maternal admission for preterm labour | Number of days the mother was admitted to the hospital because of preterm labour | 2 weeks after expected date of birth | |
Secondary | Maternal morbidity (de?ned as thromboembolic complications, chorioamnionitis, urinary tract infection treated with antibiotics, pneumonia, endometritis, eclampsia, HELLP syndrome, death, or any other significant morbidity) | complications to the mother related to preterm labour or the insertion of the stitch | 2 weeks after expected date of birth |
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