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

Primary Purpose

Preterm Birth

Status
Not yet recruiting
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Micronised vaginal progesterone
Vaginal pessary
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring twin, vaginal pessary, vaginal progestogen, short cervix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UKM Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vaginal progestogen

Vaginal pessary

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Spontaneous preterm birth
Mean gestational age at delivery in weeks

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2020
Last Updated
March 25, 2022
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04342585
Brief Title
Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
twin, vaginal pessary, vaginal progestogen, short cervix

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaginal progestogen
Arm Type
Active Comparator
Arm Description
200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation.
Arm Title
Vaginal pessary
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Micronised vaginal progesterone
Other Intervention Name(s)
Utrogestan
Intervention Description
A diary will be given to participants to ensure compliance.
Intervention Type
Device
Intervention Name(s)
Vaginal pessary
Other Intervention Name(s)
Arabin pessary
Intervention Description
The internal diameter size will be decided based on the clinical assessment of the cervix.
Primary Outcome Measure Information:
Title
Spontaneous preterm birth
Description
Mean gestational age at delivery in weeks
Time Frame
Through study completion up to 37 weeks
Secondary Outcome Measure Information:
Title
Maternal age
Description
Mean maternal age in years
Time Frame
Pre-intervention
Title
Race
Description
Percentage of each race recruited
Time Frame
Pre-intervention
Title
Maternal body mass index
Description
Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester
Time Frame
Pre-intervention
Title
Parity
Description
Mean number of parity
Time Frame
Pre-intervention
Title
Type of twin pregnancy
Description
Chorionicity of twin pregnancy
Time Frame
Pre-intervention
Title
Type of conception
Description
Method of conception
Time Frame
Pre-intervention
Title
Gestational age at recruitment
Description
Mean gestational age at recruitment in weeks
Time Frame
Pre-intervention
Title
Gestational age at commencement of treatment
Description
Mean gestational age at commencement of treatment in weeks
Time Frame
Pre-intervention
Title
Cervical length before commencement of treatment
Description
Mean cervical length before commencement of treatment in mm
Time Frame
Pre-intervention
Title
Vaginal infection
Description
Percentage of participants with vaginal infection prior to commencement of treatment
Time Frame
Pre-intervention
Title
Previous miscarriages
Description
Percentage of participants with previous first and second trimester miscarriages
Time Frame
Pre-intervention
Title
Pre-existing medical disorders
Description
Percentage of participants with pre-existing medical disorders
Time Frame
Pre-intervention
Title
Previous spontaneous preterm birth
Description
Percentage of participants with previous spontaneous preterm birth
Time Frame
Pre-intervention
Title
Antenatal complications
Description
Percentage of participants with antenatal complications
Time Frame
Through study completion up to 37 weeks
Title
Fetal complications
Description
Percentage of participants with fetal complications
Time Frame
Through study completion up to 37 weeks
Title
Mode of delivery
Description
Percentage of participants who delivered vaginally or via caesarean section
Time Frame
Through study completion up to 37 weeks
Title
Intrapartum complications
Description
Percentage of participants with intrapartum complications
Time Frame
Throughout labour up to delivery of the neonate
Title
Postpartum complications
Description
Percentage of participants with postpartum complications
Time Frame
Through delivery of neonate up to 42 days after delivery
Title
Total blood loss
Description
Mean total blood loss in ml
Time Frame
Through delivery of neonate up to 42 days after delivery
Title
Birth weight
Description
Mean birth weight in grams
Time Frame
Immediately after birth of neonate
Title
Apgar score
Description
Mean Apgar score
Time Frame
Immediately after birth of neonate
Title
Anthropometry assessment of neonates
Description
Mean length and head circumference of neonates at birth in cm
Time Frame
Immediately after birth of neonate
Title
Neonatal intensive care unit admission
Description
Percentage of neonates required Neonatal intensive care unit admission
Time Frame
Immediately after birth of neonate up to discharge (approximately 30 days)
Title
Duration in neonatal intensive care unit
Description
Mean duration in neonatal intensive care unit in days
Time Frame
Through neonatal intensive care unit stay up to discharge (approximately 30 days)
Title
Neonatal complications
Description
Percentage of neonates with complications
Time Frame
Immediately after birth up to 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
UKM Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahana Abd Rahman
Email
drrahana@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Shuhaila Ahmad
Email
shuhaila@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Nurul Ilani Abdul Latif

12. IPD Sharing Statement

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

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