Arabin Pessary in Singleton Pregnancy

Completed

• Conditions: Previous Preterm Birth; Previous Cervical Surgery; Previous Mid Trimester Miscarriage; Short Cervix on Ultrasound

• Registration Number: NCT04638023
• Lead Sponsor: National University of Malaysia

Brief Summary

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

• Study Start: 2017-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-15
• Study First Posted: 2020-11-20
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

• all women high risk for spontaneous preterm birth

Exclusion Criteria

• had Arabin insertion elsewhere
• delivered elsewhere
• incomplete record

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth at or more than 34 weeks	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

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

Trial Locations

Locations (1)

National University of Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia