Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-09-30

Brief Summary

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A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.

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Detailed Description

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This is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. Two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All women with twin pregnancies will be screened for suitability via measurement of the cervical length at 20 to 24 weeks gestation. Those with a cervical length of 30mm or less will be recruited into the study.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaginal progestogen

200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation.

Group Type ACTIVE_COMPARATOR

Micronised vaginal progesterone

Intervention Type DRUG

A diary will be given to participants to ensure compliance.

Vaginal pessary

Vaginal pessary with an internal diameter size of 32 or 35 mm will be inserted at the time of recruitment and kept until 34 weeks gestation.

Group Type ACTIVE_COMPARATOR

Vaginal pessary

Intervention Type DEVICE

The internal diameter size will be decided based on the clinical assessment of the cervix.

Interventions

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Micronised vaginal progesterone

A diary will be given to participants to ensure compliance.

Intervention Type DRUG

Vaginal pessary

The internal diameter size will be decided based on the clinical assessment of the cervix.

Intervention Type DEVICE

Other Intervention Names

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Utrogestan Arabin pessary

Eligibility Criteria

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Inclusion Criteria

* all twin pregnancies
* cervical length less than 30mm

Exclusion Criteria

* Twin to twin transfusion syndrome
* Stillbirth
* congenital anomaly in one of the fetuses
* previous cervical trauma or surgery
* cervical cerclage in current pregnancy
* premature labour with or without rupture of membranes
* severe vaginal discharge
* acute vaginitis or cervicitis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes