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

NCT04342585 | Completed Phase 3 DMC

• 2 other identifiers: JEP-2020-065DIP-2019-028
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Birth

Keywords

twin; vaginal pessary; vaginal progestogen; short cervix

Outcome Measures

Primary Outcomes (1)

• Spontaneous preterm birth

  Mean gestational age at delivery in weeks

  Through study completion up to 37 weeks

Secondary Outcomes (25)

• Maternal age

  Pre-intervention

• Race

  Pre-intervention

• Maternal body mass index

  Pre-intervention

• Parity

  Pre-intervention

• Type of twin pregnancy

  Pre-intervention

Study Arms (2)

Vaginal progestogen

ACTIVE COMPARATOR

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

Drug: Micronised vaginal progesterone

Vaginal pessary

ACTIVE COMPARATOR

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.

Device: Vaginal pessary

Interventions

Micronised vaginal progesterone DRUG

A diary will be given to participants to ensure compliance.

Also known as: Utrogestan

Vaginal progestogen

Vaginal pessary DEVICE

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

Also known as: Arabin pessary

Vaginal pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all twin pregnancies
• cervical length less than 30mm

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Utrogestan; Pessaries

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-primary investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 13, 2020
• Study Start: October 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

MY (1)