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

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

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

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Drug: Micronised vaginal progesterone; Device: Vaginal pessary

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • UKM Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vaginal progestogen; 200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation.	Drug: Micronised vaginal progesterone; A diary will be given to participants to ensure compliance.; Other Names: Utrogestan
Active Comparator: 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.	Device: Vaginal pessary; The internal diameter size will be decided based on the clinical assessment of the cervix.; Other Names: Arabin pessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous preterm birth	Mean gestational age at delivery in weeks	Through study completion up to 37 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: short cervix; twin; vaginal pessary; vaginal progestogen
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: JEP-2020-065; DIP-2019-028 (Other Grant/Funding Number: Dana Impak Perdana)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No