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

Sponsor

National University of Malaysia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04342585

Collaborator

(none)

310

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Drug: Micronised vaginal progesterone Device: Vaginal pessary	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

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.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)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Spontaneous preterm birth [Through study completion up to 37 weeks]
Mean gestational age at delivery in weeks

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UKM Medical Centre	Cheras	Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

National University of Malaysia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rahana Abd Rahman, Co-primary investigator, National University of Malaysia

ClinicalTrials.gov Identifier:

NCT04342585

Other Study ID Numbers:

JEP-2020-065
DIP-2019-028

First Posted:

Apr 13, 2020

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rahana Abd Rahman, Co-primary investigator, National University of Malaysia

Additional relevant MeSH terms:

Premature Birth

Progesterone

Study Results

No Results Posted as of Mar 28, 2022