Arabin Pessary in Singleton Pregnancy

Previous Cervical Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638023
• Other study ID #: FF-2017-372
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: November 2020
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all women high risk for spontaneous preterm birth

Exclusion Criteria:

• had Arabin insertion elsewhere

• delivered elsewhere

• incomplete record

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Premature Birth
• Previous Cervical Surgery
• Previous Mid Trimester Miscarriage
• Previous Preterm Birth
• Short Cervix on Ultrasound

Intervention

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.

Locations

Country	Name	City	State
Malaysia	National University of Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

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