Previous Mid Trimester MiscarriageNCT04638023
Arabin Pessary in Singleton Pregnancy
An observational study of Previous Mid Trimester Miscarriage and Previous Preterm Birth, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This was a retrospective study sharing the experience of women high risk for spontaneous preterm birth managed by Arabin pessary. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Previous Mid Trimester Miscarriage, Previous Preterm Birth, Previous Cervical Surgery
- What is being tested?
- Arabin pessary
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2017to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women high risk for spontaneous preterm birth who were managed with Arabin pessary were included.
Who may be able to join
- all women high risk for spontaneous preterm birth
Who cannot join
- had Arabin insertion elsewhere
- delivered elsewhere
- incomplete record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arabin Pessary Use in Women at High Risk for Preterm Birth: 7 Years' Experience in a Single Tertiary Centre
This was a retrospective study sharing the experience of women high risk for spontaneous preterm birth managed by Arabin pessary.
Read the 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.
- Conditions
- Previous Mid Trimester Miscarriage, Previous Preterm Birth, Previous Cervical Surgery, Short Cervix on Ultrasound
- Being tested
- Arabin pessary
- Keywords
- Arabin pessary, spontaneous preterm birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabin pessaryDevice
Arabin pessary was inserted intravaginally electively in women with cervical insufficiency (history based) or as emergency in those with short cervix on ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth at or more than 34 weeks
Gestation of birth in percentage that occurred at or more than 34 weeks gestation
Measured: From insertion of the Arabin pessary until birth of the foetus
Secondary outcomes (8)
Type of labour
Type of labour whether spontaneous or induced
Measured: From insertion of the Arabin pessary until birth of the foetus
Mode of delivery
Mode of delivery whether vaginal or caesarean section
Measured: From onset of labour until birth of the foetus
Median birth weight
Median neonatal birth weight in gram
Measured: At birth
Admission into neonatal intensive care unit
The need to admit the neonate to neonatal care intensive care unit at birth
Measured: At birth until discharged from the hospital
Mean cervical length
The mean cervical length at insertion of the Arabin pessary
Measured: At insertion of the Arabin pessary
Subsequent management
The management of the patients after insertion of the Arabin pessary
Measured: From insertion of Arabin pessary until birth of the foetus
Combination with progestogen therapy
Addition of progestogen therapy either vaginally or parenterally
Measured: from insertion of Arabin pessary until birth of the foetus
Complications
Antenatal complications such as diabetes, hypertension and rupture of membranes
Measured: From insertion of Arabin pessary until birth of the foetus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Previous Mid Trimester MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
- Investigators
- Rahana Abd Rahman, Principal investigator, UKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638023
- Sponsor's protocol ID
- FF-2017-372
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Methodology
Publications
Rahman RA, Atan IK, Ali A, Kalok AM, Ismail NAM, Mahdy ZA, Ahmad S. Use of the Arabin pessary in women at high risk for preterm birth: long-term experience at a single tertiary center in Malaysia. BMC Pregnancy Childbirth. 2021 May 10;21(1):368. doi: 10.1186/s12884-021-03838-x.
PubMed 33971828
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arabin Pessary Use in Women at High Risk for Preterm Birth: 7 Years' Experience in a Single Tertiary Centre
- ClinicalTrials.gov ID
- NCT04638023
- Acronym / sponsor ID
- FF-2017-372
- Conditions
- Previous Mid Trimester Miscarriage, Previous Preterm Birth, Previous Cervical Surgery, Short Cervix on Ultrasound
- Keywords
- Arabin pessary, spontaneous preterm birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women high risk for spontaneous preterm birth who were managed with Arabin pessary were included.
Key inclusion criteria (1 listed)
- all women high risk for spontaneous preterm birth
Key exclusion criteria (3 listed)
- had Arabin insertion elsewhere
- delivered elsewhere
- incomplete record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabin pessaryArabin pessary was inserted intravaginally electively in women with cervical insufficiency (history based) or as emergency in those with short cervix on ultrasound. | Device | – |
Primary outcome
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
8 secondary outcomes
Type of labour
Time frame: From insertion of the Arabin pessary until birth of the foetus
Mode of delivery
Time frame: From onset of labour until birth of the foetus
Median birth weight
Time frame: At birth
Admission into neonatal intensive care unit
Time frame: At birth until discharged from the hospital
Mean cervical length
Time frame: At insertion of the Arabin pessary
Subsequent management
Time frame: From insertion of Arabin pessary until birth of the foetus
Combination with progestogen therapy
Time frame: from insertion of Arabin pessary until birth of the foetus
Complications
Time frame: From insertion of Arabin pessary until birth of the foetus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 33971828Rahman RA, Atan IK, Ali A, Kalok AM, Ismail NAM, Mahdy ZA, Ahmad S. Use of the Arabin pessary in women at high risk for preterm birth: long-term experience at a single tertiary center in Malaysia. BMC Pregnancy Childbirth. 2021 May 10;21(1):368. doi: 10.1186/s12884-021-03838-x.
- Individual participant dataSharing planned: No. Methodology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahana Abd Rahman principal investigator
UKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Previous Mid Trimester Miscarriage and Previous Preterm Birth, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth at or more than 34 weeks (time frame: From insertion of the Arabin pessary until birth of the foetus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.