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

NCT03818867 | Unknown

• 1 other identifier: 17.004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Twin Pregnancy With Antenatal Problem; Twin to Twin Transfusion Syndrome

Keywords

cervical cerclage; Preterm Birth; Twin pregnancy; Twin to Twin Transfusion Syndrome

Outcome Measures

Primary Outcomes (1)

• Time to delivery (from randomisation to birth).

  Time between randomisation and delivery in days

  2 weeks after expected date of birth

Secondary Outcomes (10)

• Gestation at delivery

  2 weeks after expected date of birth

• Preterm birth before 28, 32 and 34 weeks' gestation

  2 weeks after expected date of birth

• Birthweight

  42 days (28 days neonatal period+2 weeks postdates)

• Stillbirth

  42 days (28 days neonatal period+2 weeks postdates)

• Neonatal death

  42 days (28 days neonatal period+2 weeks postdates)

Study Arms (2)

Cerclage arm

EXPERIMENTAL

Pregnancies which had cervical cerclage inserted.

Procedure: Insertion of cervical cerclage

No-cerclage arm

NO INTERVENTION

Pregnancies which did not have cervical cerclage inserted.

Interventions

Insertion of cervical cerclage PROCEDURE

insertion of a stitch around the neck of the womb in order to provide extra support.

Also known as: cervical stitch

Cerclage arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's Hospital

London, SW17 0QT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth; Fetofetal Transfusion

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Asma Khalil

  St George's NHS Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asma Khalil

CONTACT

7917400164; akhalil@sgul.ac.uk

Rosemary Townsend

CONTACT

rosemary.townsend1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: May 15, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

GB (1)