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

Sponsors

Lead Sponsor: National University of Malaysia

Source 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.

Overall Status Not yet recruiting
Start Date July 1, 2020
Completion Date July 31, 2022
Primary Completion Date April 1, 2022
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Spontaneous preterm birth Through study completion up to 37 weeks
Secondary Outcome
Measure Time Frame
Maternal age Pre-intervention
Race Pre-intervention
Maternal body mass index Pre-intervention
Parity Pre-intervention
Type of twin pregnancy Pre-intervention
Type of conception Pre-intervention
Gestational age at recruitment Pre-intervention
Gestational age at commencement of treatment Pre-intervention
Cervical length before commencement of treatment Pre-intervention
Vaginal infection Pre-intervention
Previous miscarriages Pre-intervention
Pre-existing medical disorders Pre-intervention
Previous spontaneous preterm birth Pre-intervention
Antenatal complications Through study completion up to 37 weeks
Fetal complications Through study completion up to 37 weeks
Mode of delivery Through study completion up to 37 weeks
Intrapartum complications Throughout labour up to delivery of the neonate
Postpartum complications Through delivery of neonate up to 42 days after delivery
Total blood loss Through delivery of neonate up to 42 days after delivery
Birth weight Immediately after birth of neonate
Apgar score Immediately after birth of neonate
Anthropometry assessment of neonates Immediately after birth of neonate
Neonatal intensive care unit admission Immediately after birth of neonate up to discharge (approximately 30 days)
Duration in neonatal intensive care unit Through neonatal intensive care unit stay up to discharge (approximately 30 days)
Neonatal complications Immediately after birth up to 30 days
Enrollment 310
Condition
Intervention

Intervention Type: Drug

Intervention Name: Micronised vaginal progesterone

Description: A diary will be given to participants to ensure compliance.

Arm Group Label: Vaginal progestogen

Other Name: Utrogestan

Intervention Type: Device

Intervention Name: Vaginal pessary

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

Arm Group Label: Vaginal pessary

Other Name: Arabin pessary

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Contact: Contact Backup: Investigator: UKM Medical Centre Rahana Abd Rahman [email protected] Nurul Ilani Abdul Latif Principal Investigator
Location Countries

Malaysia

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University of Malaysia

Investigator Full Name: Rahana Abd Rahman

Investigator Title: Co-primary investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Vaginal progestogen

Type: Active Comparator

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

Label: Vaginal pessary

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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.

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov