Preterm BirthENCIRCLENCT03818867
Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial
A study testing Insertion of cervical cerclage in people with Preterm Birth and Twin Pregnancy With Antenatal Problem, run by St George's, University of London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Twin Pregnancy With Antenatal Problem, Twin to Twin Transfusion Syndrome
- What is being tested?
- Insertion of cervical cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Rosemary Townsend contact
United Kingdom1 site, 1 recruiting
- Recruiting
St George's Hospital
London, SW17 0QT
Asma Khalil, 7917400164, akhalil@sgul.ac.uk
Rosemary Townsend, rosemary.townsend1@nhs.net
About this study
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.
Read the 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.
- Being tested
- Insertion of cervical cerclage
- Keywords
- cervical cerclage, Preterm Birth, Twin pregnancy, Twin to Twin Transfusion Syndrome
- Medical subject headings
- Premature Birth, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of cervical cerclageProcedure or surgery
Also called cervical stitch
insertion of a stitch around the neck of the womb in order to provide extra support.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage arm | Experimental | Pregnancies which had cervical cerclage inserted. Receives: Procedure: Insertion of cervical cerclage |
| No-cerclage arm | No intervention | Pregnancies which did not have cervical cerclage inserted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to delivery (from randomisation to birth).
Time between randomisation and delivery in days
Measured: 2 weeks after expected date of birth
Secondary outcomes (10)
Gestation at delivery
gestational age at delivery in weeks
Measured: 2 weeks after expected date of birth
Preterm birth before 28, 32 and 34 weeks' gestation
the proportion of women giving birth before 28, 32 and 34 weeks
Measured: 2 weeks after expected date of birth
Birthweight
birth weight in grams
Measured: 42 days (28 days neonatal period+2 weeks postdates)
Stillbirth
death of the fetus (after 24 weeks) and before birth
Measured: 42 days (28 days neonatal period+2 weeks postdates)
Neonatal death
the death of a baby within the first 28 days of life
Measured: 42 days (28 days neonatal period+2 weeks postdates)
Survival to discharge
the proportion of the babies surviving until discharge from the hospital after birth
Measured: 42 days (28 days neonatal period+2 weeks postdates)
Days of admission to the neonatal intensive care unit
Number of days the baby was admitted in the neonatal intensive care unit
Measured: 42 days (28 days neonatal period+2 weeks postdates)
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)
Measured: 42 days (28 days neonatal period+2 weeks postdates)
Days of maternal admission for preterm labour
Number of days the mother was admitted to the hospital because of preterm labour
Measured: 2 weeks after expected date of birth
Maternal morbidity (defined 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
Measured: 2 weeks after expected date of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start15 May 2017
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asma Khalil, Principal investigator, St George's NHS Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818867
- Sponsor's protocol ID
- 17.004
- Acronym
- ENCIRCLE
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03818867
- Acronym / sponsor ID
- ENCIRCLE / 17.004
- Keywords
- cervical cerclage, Preterm Birth, Twin pregnancy, Twin to Twin Transfusion Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerclage arm | Experimental | Procedure: Insertion of cervical cerclagePregnancies which had cervical cerclage inserted. |
| No-cerclage arm | No intervention | –Pregnancies which did not have cervical cerclage inserted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of cervical cerclageAlso: cervical stitchinsertion of a stitch around the neck of the womb in order to provide extra support. | Procedure or surgery | Cerclage arm |
Primary outcome
Time to delivery (from randomisation to birth).
Time frame: 2 weeks after expected date of birth
Time between randomisation and delivery in days
10 secondary outcomes
Gestation at delivery
Time frame: 2 weeks after expected date of birth
Preterm birth before 28, 32 and 34 weeks' gestation
Time frame: 2 weeks after expected date of birth
Birthweight
Time frame: 42 days (28 days neonatal period+2 weeks postdates)
Stillbirth
Time frame: 42 days (28 days neonatal period+2 weeks postdates)
Neonatal death
Time frame: 42 days (28 days neonatal period+2 weeks postdates)
Survival to discharge
Time frame: 42 days (28 days neonatal period+2 weeks postdates)
Days of admission to the neonatal intensive care unit
Time frame: 42 days (28 days neonatal period+2 weeks postdates)
Composite outcome
Time frame: 42 days (28 days neonatal period+2 weeks postdates)
Days of maternal admission for preterm labour
Time frame: 2 weeks after expected date of birth
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Townsend contact
Asma Khalil principal investigator
St George's NHS Healthcare Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of cervical cerclage in people with Preterm Birth and Twin Pregnancy With Antenatal Problem, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asma Khalil (7917400164, akhalil@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to delivery (from randomisation to birth). (time frame: 2 weeks after expected date of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.