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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
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Time to delivery (from randomisation to birth). [ Time Frame: 2 weeks after expected date of birth ]
    Time between randomisation and delivery in days


Secondary Outcome Measures :
  1. Gestation at delivery [ Time Frame: 2 weeks after expected date of birth ]
    gestational age at delivery in weeks

  2. 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

  3. Birthweight [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]
    birth weight in grams

  4. Stillbirth [ Time Frame: 42 days (28 days neonatal period+2 weeks postdates) ]
    death of the fetus (after 24 weeks) and before birth

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Asma Khalil 7917400164 akhalil@sgul.ac.uk
Contact: Rosemary Townsend rosemary.townsend1@nhs.net

Locations
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United Kingdom
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact: Asma Khalil    7917400164    akhalil@sgul.ac.uk   
Contact: Rosemary Townsend       rosemary.townsend1@nhs.net   
Sponsors and Collaborators
St George's, University of London
Investigators
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Principal Investigator: Asma Khalil St George's NHS Healthcare Trust
  Study Documents (Full-Text)

Documents provided by St George's, University of London:
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03818867    
Other Study ID Numbers: 17.004
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St George's, University of London:
cervical cerclage
Preterm Birth
Twin pregnancy
Twin to Twin Transfusion Syndrome
Additional relevant MeSH terms:
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Premature Birth
Fetofetal Transfusion
Emergencies
Pathologic Processes
Disease Attributes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases