Arabin Pessary in Singleton Pregnancy

Sponsor

National University of Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT04638023

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

all women high risk for spontaneous preterm birth

Exclusion Criteria:

had Arabin insertion elsewhere
delivered elsewhere
incomplete record

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University of Malaysia	Cheras	Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

National University of Malaysia

Investigators

Principal Investigator: Rahana Abd Rahman, UKM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rahana Abd Rahman, Assoc. Prof., National University of Malaysia

ClinicalTrials.gov Identifier:

NCT04638023

Other Study ID Numbers:

FF-2017-372

First Posted:

Nov 20, 2020

Last Update Posted:

Nov 24, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rahana Abd Rahman, Assoc. Prof., National University of Malaysia

Arabin pessary, spontaneous preterm birth

Additional relevant MeSH terms:

Premature Birth

Abortion, Spontaneous

Study Results

No Results Posted as of Nov 24, 2020