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Trial registered on ANZCTR

Registration number

ACTRN12616000875404

Ethics application status

Approved

Date submitted

30/06/2016

Date registered

5/07/2016

Date last updated

15/09/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Pessary or Progesterone to Prevent Preterm delivery in women with a twin pregnancy and short cervical length

Scientific title

Evaluating the effectiveness of a cervical pessary to improve neonatal outcome by preventing preterm birth in women with a twin pregnancy and a short cervix.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

U1111-1184-7682

Trial acronym

Quad P-twins

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Short cervix in twin pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Cerclage pessary.

This is a dome shaped silicone device which is inserted into the vagina by an obstetrician. The cerclage pessary will remain in place from the time of insertion (approx 20 weeks gestation) until approximately 36 weeks gestation, or the onset of labour, whichever occurs first.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Intervention code [3]

Treatment: Devices

Comparator / control treatment

Vaginal progesterone.

Progesterone capsules containing 200mg micronised progesterone. These will be self administered by participants by placing one capsule into the vagina each night. Treatment will be from study entry ( at approx 20 weeks gestation) until approximately 36 weeks gestation, or the onset of labour, whichever occurs first.

Control group

Active

Outcomes

Primary outcome [1]

Composite adverse neonatal outcome icluding periventricular leukomalacia (PVL) > grade 1, severe respiratory distress syndrome (RDS) bronchopulmonary Dyplasia (BPD), Intraventricular Haemorrhage grade III or IV, Necrotizing Enterocolitis (NEC) > stage 1, proven sepsis, (intrapartum) stillbirth and death before discharge from the nursery. These will be assessed by review of medical records.

Timepoint [1]

Time of delivery

Secondary outcome [1]

Time to delivery
Preterm birth rates at 38, 32, 34, and 37 weeks gestation.
These will be assessed by medical record review

Timepoint [1]

Time of delivery

Eligibility

Key inclusion criteria

Viable twin pregnancy
Cervical length less than 38mm via transvaginal ultrasound assessment

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Placenta praevia
Cervical cerclage in this pregnancy
Identified major congenital anomaly
Demise of one or both twins
previous preterm birth (including of singleton)
Previous participation in the Quad P-twin study

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Treatment allocation will NOT be concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software. Stratified by site

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Data will initially be analysed according the intention to treat and outcome assessors will be blinded to treatment allocation. The main outcome variable will be assessed by calculating rates in the two groups, relative risks and 95% confidence intervals as well as numbers needed to treat. To evaluate the potential of each of the strategies, we will also perform a per protocol analysis, taking into account only those cases that were treated according to protocol.
A poor outcome rate of 15% is expected. The aim of the study is to exclude that the difference between the two groups is more than 15%. Using a power of 80% we need 89 subjects in each arm. However as each pregnancy will result in the birth of two children and there will be a dependency between the children born of one mother, it is sufficient to recruit 70 women per arm (140 in total).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2016

Actual

Date of last participant enrolment

Anticipated

31/08/2018

Actual

Date of last data collection

Anticipated

28/02/2019

Actual

Sample size

Target

140

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [2]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5006 - North Adelaide

Recruitment postcode(s) [2]

5112 - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Women's and Children's Hospital Foundation

Address [1]

55 King William Rd, North Adelaide SA 5006

Country [1]

Australia

Primary sponsor type

Hospital

Name

Women's and Children's Health Network

Address

72 King William Rd, North Adelaide SA 5006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee (EC00197)

Ethics committee address [1]

72 King William Road,  NORTH ADELAIDE  SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2016

Approval date [1]

27/06/2016

Ethics approval number [1]

HREC/16/WCHN/13

Summary

Brief summary

Preterm birth, defined as birth before 37 weeks gestation, affects 22,000 pregnancies (7.5%) in Australia each year. While advances in neonatal care and treatments for preterm babies have greatly increased the chances of survival for even the smallest babies, preterm birth is still the leading cause of newborn death. Babies born before 37 weeks are also at risk for serious health problems including breathing difficulties, feeding problems, jaundice and effects on brain functions.

Multiple pregnancy is a major risk factor for preterm birth, with 57% of twins born preterm compared to only 7% of singletons. Furthermore, 12% of twins are born before 32 weeks compared with only 2% of singletons. 

A short cervix, as measured by transvaginal ultrasound during the second trimester, is a powerful predictor of preterm birth. The risk of preterm delivery increases as the cervix shortens. When cervical length is less than 22 mm, women face a 20% probability of preterm delivery, which increases to 50% when the cervical length is less than 15 mm. 

Two currently available treatments used to reduce the incidence of preterm delivery in high risk women include the cerclage pessary and progesterone. Both of these interventions have been shown to effectively reduce the incidence of preterm birth in women with a short cervix. However, up until now, no study has directly compared the effectiveness of these two treatment options in women with twins. The purpose of this study is to directly compare the effectiveness of progesterone and cerclage pessaries in preventing preterm birth in women with a short cervix and twin pregnancy. Currently there is no standard treatment for short cervix in twin pregnancies. The standard treatment in singleton pregnancies is to offer progesterone.  While the cerclage pessary is not widely used in Australia, it is widely used in Europe.  A number of sites in Australia do use the cerclage pessary where they think it will be helpful.

This study is similar to a larger one currently being conducted in the Netherlands.  We will be watching that study closely to see if any of it’s outcomes inform us regarding the conduct of this study here in South Australia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ben Mol

Address

The University of Adelaide
University Department of Obstetrics and Gynaecology,
Level I, Queen Victoria Building,
72 King William Rd.,
NORTH ADELAIDE SA 5006

Country

Australia

Phone

+61 8 81617619

Fax

ben.mol@adelaide.edu.au

Contact person for public queries

Name

Suzette Coat

Address

Robinson Research Institute,
Level 3, 55 King William Rd.,
NORTH ADELAIDE SA 5006

Country

Australia

Phone

+61 8 8313 1338

Fax

suzette.coat@adelaide.edu.au

Contact person for scientific queries

Name

Ben Mol

Address

The University of Adelaide
University Department of Obstetrics and Gynaecology,
Level I, Queen Victoria Building,
72 King William Rd.,
NORTH ADELAIDE SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

ben.mol@adelaide.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.	2017	https://dx.doi.org/10.1002/14651858.CD012024.pub2
Embase	Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2-a study protocol.	2018	https://dx.doi.org/10.1136/bmjopen-2018-026430

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically