NCT04638023

Brief Summary

This was a retrospective study sharing the experience of women high risk for spontaneous preterm birth managed by Arabin pessary.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 15, 2020

Last Update Submit

November 20, 2020

Conditions

Previous Mid Trimester MiscarriagePrevious Preterm BirthPrevious Cervical SurgeryShort Cervix on Ultrasound

Keywords

Arabin pessary, spontaneous preterm birth

Outcome Measures

Primary Outcomes (1)

  • Birth at or more than 34 weeks

    Gestation of birth in percentage that occurred at or more than 34 weeks gestation

    From insertion of the Arabin pessary until birth of the foetus

Secondary Outcomes (8)

  • Type of labour

    From insertion of the Arabin pessary until birth of the foetus

  • Mode of delivery

    From onset of labour until birth of the foetus

  • Median birth weight

    At birth

  • Admission into neonatal intensive care unit

    At birth until discharged from the hospital

  • Mean cervical length

    At insertion of the Arabin pessary

  • +3 more secondary outcomes

Interventions

Arabin pessaryDEVICE

Arabin pessary was inserted intravaginally electively in women with cervical insufficiency (history based) or as emergency in those with short cervix on ultrasound.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women high risk for spontaneous preterm birth who were managed with Arabin pessary were included.

You may qualify if:

  • all women high risk for spontaneous preterm birth

You may not qualify if:

  • had Arabin insertion elsewhere
  • delivered elsewhere
  • incomplete record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

  • Rahman RA, Atan IK, Ali A, Kalok AM, Ismail NAM, Mahdy ZA, Ahmad S. Use of the Arabin pessary in women at high risk for preterm birth: long-term experience at a single tertiary center in Malaysia. BMC Pregnancy Childbirth. 2021 May 10;21(1):368. doi: 10.1186/s12884-021-03838-x.

    PMID: 33971828DERIVED

Study Officials

  • Rahana Abd Rahman

    UKM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 20, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Methodology

Locations

MY(1)