Preterm Birth Clinical Trial
Official title:
Study Title: Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial
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.
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
Study population:
2 groups
- 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.
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