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

Phase 3

Completed

• Conditions: Preterm Birth
• Interventions: Drug: Micronised vaginal progesterone; Device: Vaginal pessary

• Registration Number: NCT04342585
• Lead Sponsor: National University of Malaysia

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progestogen	Micronised vaginal progesterone	200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation.
Vaginal pessary	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.

Primary Outcome Measures

Name	Time	Method
Spontaneous preterm birth	Through study completion up to 37 weeks	Mean gestational age at delivery in weeks

Secondary Outcome Measures

Name	Time	Method
Type of twin pregnancy	Pre-intervention	Chorionicity of twin pregnancy
Type of conception	Pre-intervention	Method of conception
Maternal age	Pre-intervention	Mean maternal age in years
Race	Pre-intervention	Percentage of each race recruited
Maternal body mass index	Pre-intervention	Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester
Parity	Pre-intervention	Mean number of parity
Gestational age at recruitment	Pre-intervention	Mean gestational age at recruitment in weeks
Gestational age at commencement of treatment	Pre-intervention	Mean gestational age at commencement of treatment in weeks
Cervical length before commencement of treatment	Pre-intervention	Mean cervical length before commencement of treatment in mm
Vaginal infection	Pre-intervention	Percentage of participants with vaginal infection prior to commencement of treatment
Previous miscarriages	Pre-intervention	Percentage of participants with previous first and second trimester miscarriages
Pre-existing medical disorders	Pre-intervention	Percentage of participants with pre-existing medical disorders
Previous spontaneous preterm birth	Pre-intervention	Percentage of participants with previous spontaneous preterm birth
Antenatal complications	Through study completion up to 37 weeks	Percentage of participants with antenatal complications
Fetal complications	Through study completion up to 37 weeks	Percentage of participants with fetal complications
Mode of delivery	Through study completion up to 37 weeks	Percentage of participants who delivered vaginally or via caesarean section
Intrapartum complications	Throughout labour up to delivery of the neonate	Percentage of participants with intrapartum complications
Postpartum complications	Through delivery of neonate up to 42 days after delivery	Percentage of participants with postpartum complications
Total blood loss	Through delivery of neonate up to 42 days after delivery	Mean total blood loss in ml
Birth weight	Immediately after birth of neonate	Mean birth weight in grams
Neonatal complications	Immediately after birth up to 30 days	Percentage of neonates with complications
Apgar score	Immediately after birth of neonate	Mean Apgar score
Anthropometry assessment of neonates	Immediately after birth of neonate	Mean length and head circumference of neonates at birth in cm
Duration in neonatal intensive care unit	Through neonatal intensive care unit stay up to discharge (approximately 30 days)	Mean duration in neonatal intensive care unit in days
Neonatal intensive care unit admission	Immediately after birth of neonate up to discharge (approximately 30 days)	Percentage of neonates required Neonatal intensive care unit admission

Trial Locations

Locations (1)

UKM Medical Centre; 🇲🇾 Cheras, Kuala Lumpur, Malaysia