Skip to main content
OpenTrials
Completed

NCT Number: NCT04342585

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micronised vaginal progesterone

Drug

A diary will be given to participants to ensure compliance.

Other names: Utrogestan

vaginal pessary

Device

The internal diameter size will be decided based on the clinical assessment of the cervix.

Other names: Arabin pessary

Primary outcomes

  1. Spontaneous preterm birth

    Time frame: Through study completion up to 37 weeks

    Mean gestational age at delivery in weeks

Secondary outcomes

  1. Maternal age

    Time frame: Pre-intervention

    Mean maternal age in years

  2. Race

    Time frame: Pre-intervention

    Percentage of each race recruited

  3. Maternal body mass index

    Time frame: Pre-intervention

    Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester

  4. Parity

    Time frame: Pre-intervention

    Mean number of parity

  5. Type of twin pregnancy

    Time frame: Pre-intervention

    Chorionicity of twin pregnancy

  6. Type of conception

    Time frame: Pre-intervention

    Method of conception

  7. Gestational age at recruitment

    Time frame: Pre-intervention

    Mean gestational age at recruitment in weeks

  8. Gestational age at commencement of treatment

    Time frame: Pre-intervention

    Mean gestational age at commencement of treatment in weeks

  9. Cervical length before commencement of treatment

    Time frame: Pre-intervention

    Mean cervical length before commencement of treatment in mm

  10. Vaginal infection

    Time frame: Pre-intervention

    Percentage of participants with vaginal infection prior to commencement of treatment

  11. Previous miscarriages

    Time frame: Pre-intervention

    Percentage of participants with previous first and second trimester miscarriages

  12. Pre-existing medical disorders

    Time frame: Pre-intervention

    Percentage of participants with pre-existing medical disorders

  13. Previous spontaneous preterm birth

    Time frame: Pre-intervention

    Percentage of participants with previous spontaneous preterm birth

  14. Antenatal complications

    Time frame: Through study completion up to 37 weeks

    Percentage of participants with antenatal complications

  15. Fetal complications

    Time frame: Through study completion up to 37 weeks

    Percentage of participants with fetal complications

  16. Mode of delivery

    Time frame: Through study completion up to 37 weeks

    Percentage of participants who delivered vaginally or via caesarean section

  17. Intrapartum complications

    Time frame: Throughout labour up to delivery of the neonate

    Percentage of participants with intrapartum complications

  18. Postpartum complications

    Time frame: Through delivery of neonate up to 42 days after delivery

    Percentage of participants with postpartum complications

  19. Total blood loss

    Time frame: Through delivery of neonate up to 42 days after delivery

    Mean total blood loss in ml

  20. Birth weight

    Time frame: Immediately after birth of neonate

    Mean birth weight in grams

  21. Apgar score

    Time frame: Immediately after birth of neonate

    Mean Apgar score

  22. Anthropometry assessment of neonates

    Time frame: Immediately after birth of neonate

    Mean length and head circumference of neonates at birth in cm

  23. Neonatal intensive care unit admission

    Time frame: Immediately after birth of neonate up to discharge (approximately 30 days)

    Percentage of neonates required Neonatal intensive care unit admission

  24. Duration in neonatal intensive care unit

    Time frame: Through neonatal intensive care unit stay up to discharge (approximately 30 days)

    Mean duration in neonatal intensive care unit in days

  25. Neonatal complications

    Time frame: Immediately after birth up to 30 days

    Percentage of neonates with complications

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2020
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.