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

National University of Malaysia

Status and phase: Completed; Phase 3

Conditions: Preterm Birth

Treatments: Device: Vaginal pessary; Drug: Micronised vaginal progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT04342585

JEP-2020-065

DIP-2019-028 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 142 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Vaginal progestogen

Active Comparator group

Description:

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

Treatment:

Drug: Micronised vaginal progesterone

Vaginal pessary

Active Comparator group

Description:

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.

Treatment:

Device: Vaginal pessary