Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial

Brief Title

Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial

Official Title

Study Title: Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Time to delivery (from randomisation to birth).

Secondary Outcome

 Gestation at delivery

Condition

Preterm Birth

Intervention

Insertion of cervical cerclage

Study Arms / Comparison Groups

 Cerclage arm
Description:  Pregnancies which had cervical cerclage inserted.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

31

Start Date

May 15, 2017

Completion Date

December 2019

Primary Completion Date

July 2019

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Asma Khalil, 7917400164, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03818867

Organization ID

17.004


Responsible Party

Sponsor

Study Sponsor

St George's, University of London


Study Sponsor

Asma Khalil, Principal Investigator, St George's NHS Healthcare Trust


Verification Date

January 2019