Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth

National University of Malaysia1 site in 1 country142 target enrollmentOctober 1, 2019

ConditionsPreterm Birth

InterventionsMicronised vaginal progesterone Vaginal pessary

DrugsMicronised vaginal progesterone

Overview

Phase: Phase 3
Intervention: Micronised vaginal progesterone
Conditions: Preterm Birth
Sponsor: National University of Malaysia
Enrollment: 142
Locations: 1
Primary Endpoint: Spontaneous preterm birth
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2019

End Date

September 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

National University of Malaysia

Responsible Party

Principal Investigator

Rahana Abd Rahman

Co-primary investigator

National University of Malaysia

Eligibility Criteria

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

Arms & Interventions

Vaginal progestogen

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

Intervention: Micronised vaginal progesterone

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.

Intervention: Vaginal pessary

Outcomes

Primary Outcomes

Spontaneous preterm birth

Time Frame: Through study completion up to 37 weeks

Mean gestational age at delivery in weeks

Secondary Outcomes

Maternal age(Pre-intervention)
Race(Pre-intervention)
Maternal body mass index(Pre-intervention)
Parity(Pre-intervention)
Type of twin pregnancy(Pre-intervention)
Type of conception(Pre-intervention)
Gestational age at recruitment(Pre-intervention)
Gestational age at commencement of treatment(Pre-intervention)
Cervical length before commencement of treatment(Pre-intervention)
Vaginal infection(Pre-intervention)
Previous miscarriages(Pre-intervention)
Pre-existing medical disorders(Pre-intervention)
Previous spontaneous preterm birth(Pre-intervention)
Antenatal complications(Through study completion up to 37 weeks)
Fetal complications(Through study completion up to 37 weeks)
Mode of delivery(Through study completion up to 37 weeks)
Intrapartum complications(Throughout labour up to delivery of the neonate)
Postpartum complications(Through delivery of neonate up to 42 days after delivery)
Total blood loss(Through delivery of neonate up to 42 days after delivery)
Birth weight(Immediately after birth of neonate)
Neonatal complications(Immediately after birth up to 30 days)
Apgar score(Immediately after birth of neonate)
Anthropometry assessment of neonates(Immediately after birth of neonate)
Duration in neonatal intensive care unit(Through neonatal intensive care unit stay up to discharge (approximately 30 days))
Neonatal intensive care unit admission(Immediately after birth of neonate up to discharge (approximately 30 days))