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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage arm | Experimental | Pregnancies which had cervical cerclage inserted. |
|
| No-cerclage arm | No Intervention | Pregnancies which did not have cervical cerclage inserted. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of cervical cerclage | Procedure | insertion of a stitch around the neck of the womb in order to provide extra support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to delivery (from randomisation to birth). | Time between randomisation and delivery in days | 2 weeks after expected date of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Gestation at delivery | gestational age at delivery in weeks | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asma Khalil | Contact | 7917400164 | akhalil@sgul.ac.uk | |
| Rosemary Townsend | Contact | rosemary.townsend1@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Asma Khalil | St George's NHS Healthcare Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George's Hospital | Recruiting | London | SW17 0QT | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2018 |
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| 2 weeks after expected date of birth |
| Birthweight | birth weight in grams | 42 days (28 days neonatal period+2 weeks postdates) |
| Stillbirth | death of the fetus (after 24 weeks) and before birth | 42 days (28 days neonatal period+2 weeks postdates) |
| Neonatal death | the death of a baby within the first 28 days of life | 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 | 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 | 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) | 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 | 2 weeks after expected date of birth |
| Maternal morbidity (deļ¬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 |
| Jan 23, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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