Arabin Pessary in Singleton Pregnancy

November 20, 2020 updated by: Rahana Abd Rahman, National University of Malaysia

Arabin Pessary Use in Women at High Risk for Preterm Birth: 7 Years' Experience in a Single Tertiary Centre

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study recruitment was from 1st January 2013 until 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine ultrasound. The primary outcome measure was birth before 34 weeks gestation.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • National University of Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • all women high risk for spontaneous preterm birth

Exclusion Criteria:

  • had Arabin insertion elsewhere
  • delivered elsewhere
  • incomplete record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth at or more than 34 weeks
Time Frame: From insertion of the Arabin pessary until birth of the foetus
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of labour
Time Frame: From insertion of the Arabin pessary until birth of the foetus
Type of labour whether spontaneous or induced
From insertion of the Arabin pessary until birth of the foetus
Mode of delivery
Time Frame: From onset of labour until birth of the foetus
Mode of delivery whether vaginal or caesarean section
From onset of labour until birth of the foetus
Median birth weight
Time Frame: At birth
Median neonatal birth weight in gram
At birth
Admission into neonatal intensive care unit
Time Frame: At birth until discharged from the hospital
The need to admit the neonate to neonatal care intensive care unit at birth
At birth until discharged from the hospital
Mean cervical length
Time Frame: At insertion of the Arabin pessary
The mean cervical length at insertion of the Arabin pessary
At insertion of the Arabin pessary
Subsequent management
Time Frame: From insertion of Arabin pessary until birth of the foetus
The management of the patients after insertion of the Arabin pessary
From insertion of Arabin pessary until birth of the foetus
Combination with progestogen therapy
Time Frame: from insertion of Arabin pessary until birth of the foetus
Addition of progestogen therapy either vaginally or parenterally
from insertion of Arabin pessary until birth of the foetus
Complications
Time Frame: From insertion of Arabin pessary until birth of the foetus
Antenatal complications such as diabetes, hypertension and rupture of membranes
From insertion of Arabin pessary until birth of the foetus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Rahana Abd Rahman, UKM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

November 15, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (ACTUAL)

November 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2017-372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Methodology

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Previous Mid Trimester Miscarriage

Clinical Trials on Arabin pessary

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe