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Completed

NCT Number: NCT04638023

Arabin Pessary in Singleton Pregnancy

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

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Key information

Conditions

Previous Mid Trimester Miscarriage Previous Cervical Surgery Previous Preterm Birth Short Cervix on Ultrasound

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all women high risk for spontaneous preterm birth

Exclusion criteria

  • had Arabin insertion elsewhere
  • delivered elsewhere
  • incomplete record

Treatment and study plan

Arabin pessary

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Type of labour

    Time frame: From insertion of the Arabin pessary until birth of the foetus

    Type of labour whether spontaneous or induced

  2. Mode of delivery

    Time frame: From onset of labour until birth of the foetus

    Mode of delivery whether vaginal or caesarean section

  3. Median birth weight

    Time frame: At birth

    Median neonatal birth weight in gram

  4. 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

  5. Mean cervical length

    Time frame: At insertion of the Arabin pessary

    The mean cervical length at insertion of the Arabin pessary

  6. 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

  7. Combination with progestogen therapy

    Time frame: from insertion of Arabin pessary until birth of the foetus

    Addition of progestogen therapy either vaginally or parenterally

  8. Complications

    Time frame: From insertion of Arabin pessary until birth of the foetus

    Antenatal complications such as diabetes, hypertension and rupture of membranes

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2020
Registry last updated
Nov 24, 2020

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.

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