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Arabin Pessary in Singleton Pregnancy

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ClinicalTrials.gov Identifier: NCT04638023
Recruitment Status : Completed
First Posted : November 20, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Rahana Abd Rahman, National University of Malaysia

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

Condition or disease Intervention/treatment
Previous Mid Trimester Miscarriage Previous Preterm Birth Previous Cervical Surgery Short Cervix on Ultrasound Device: Arabin pessary

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 Design
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Arabin Pessary Use in Women at High Risk for Preterm Birth: 7 Years' Experience in a Single Tertiary Centre
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018
Groups and Cohorts
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Intervention Details:
  • Device: Arabin pessary
    Arabin pessary was inserted intravaginally electively in women with cervical insufficiency (history based) or as emergency in those with short cervix on ultrasound.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All women high risk for spontaneous preterm birth who were managed with Arabin pessary were included.
Criteria

Inclusion Criteria:

  • all women high risk for spontaneous preterm birth

Exclusion Criteria:

  • had Arabin insertion elsewhere
  • delivered elsewhere
  • incomplete record
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638023


Locations
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Malaysia
National University of Malaysia
Cheras, Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
National University of Malaysia
Investigators
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Principal Investigator: Rahana Abd Rahman UKM
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rahana Abd Rahman, Assoc. Prof., National University of Malaysia
ClinicalTrials.gov Identifier: NCT04638023    
Other Study ID Numbers: FF-2017-372
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Methodology

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rahana Abd Rahman, National University of Malaysia:
Arabin pessary, spontaneous preterm birth
Additional relevant MeSH terms:
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Premature Birth
Abortion, Spontaneous
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications