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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342585
• Other study ID #: JEP-2020-065
• Secondary ID: DIP-2019-028
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2024
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• Micronised vaginal progesterone
A diary will be given to participants to ensure compliance.

Device:
• Vaginal pessary
The internal diameter size will be decided based on the clinical assessment of the cervix.

Locations

Country	Name	City	State
Malaysia	UKM Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

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