Preterm BirthPhase 3NCT04342585
Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length
A Phase 3 study testing Micronised vaginal progesterone and Vaginal pessary in people with Preterm Birth, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Micronised vaginal progesterone and Vaginal pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2019to 30 Sep 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all twin pregnancies
- cervical length less than 30mm
Who cannot join
- Twin to twin transfusion syndrome
- Stillbirth
- congenital anomaly in one of the fetuses
- previous cervical trauma or surgery
- cervical cerclage in current pregnancy
- premature labour with or without rupture of membranes
- severe vaginal discharge
- acute vaginitis or cervicitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth
A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.
Read the detailed description
This is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. Two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.
- Conditions
- Preterm Birth
- Being tested
- Micronised vaginal progesterone, Vaginal pessary
- Keywords
- twin, vaginal pessary, vaginal progestogen, short cervix
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronised vaginal progesteroneDrug
Also called Utrogestan
A diary will be given to participants to ensure compliance.
Vaginal pessaryDevice
Also called Arabin pessary
The internal diameter size will be decided based on the clinical assessment of the cervix.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progestogen | Active comparator | 200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation. Receives: Drug: Micronised vaginal progesterone |
| Vaginal pessary | Active comparator | Vaginal pessary with an internal diameter size of 32 or 35 mm will be inserted at the time of recruitment and kept until 34 weeks gestation. Receives: Device: Vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous preterm birth
Mean gestational age at delivery in weeks
Measured: Through study completion up to 37 weeks
Secondary outcomes (25)
Maternal age
Mean maternal age in years
Measured: Pre-intervention
Race
Percentage of each race recruited
Measured: Pre-intervention
Maternal body mass index
Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester
Measured: Pre-intervention
Parity
Mean number of parity
Measured: Pre-intervention
Type of twin pregnancy
Chorionicity of twin pregnancy
Measured: Pre-intervention
Type of conception
Method of conception
Measured: Pre-intervention
Gestational age at recruitment
Mean gestational age at recruitment in weeks
Measured: Pre-intervention
Gestational age at commencement of treatment
Mean gestational age at commencement of treatment in weeks
Measured: Pre-intervention
Cervical length before commencement of treatment
Mean cervical length before commencement of treatment in mm
Measured: Pre-intervention
Vaginal infection
Percentage of participants with vaginal infection prior to commencement of treatment
Measured: Pre-intervention
Previous miscarriages
Percentage of participants with previous first and second trimester miscarriages
Measured: Pre-intervention
Pre-existing medical disorders
Percentage of participants with pre-existing medical disorders
Measured: Pre-intervention
Previous spontaneous preterm birth
Percentage of participants with previous spontaneous preterm birth
Measured: Pre-intervention
Antenatal complications
Percentage of participants with antenatal complications
Measured: Through study completion up to 37 weeks
Fetal complications
Percentage of participants with fetal complications
Measured: Through study completion up to 37 weeks
Mode of delivery
Percentage of participants who delivered vaginally or via caesarean section
Measured: Through study completion up to 37 weeks
Intrapartum complications
Percentage of participants with intrapartum complications
Measured: Throughout labour up to delivery of the neonate
Postpartum complications
Percentage of participants with postpartum complications
Measured: Through delivery of neonate up to 42 days after delivery
Total blood loss
Mean total blood loss in ml
Measured: Through delivery of neonate up to 42 days after delivery
Birth weight
Mean birth weight in grams
Measured: Immediately after birth of neonate
Apgar score
Mean Apgar score
Measured: Immediately after birth of neonate
Anthropometry assessment of neonates
Mean length and head circumference of neonates at birth in cm
Measured: Immediately after birth of neonate
Neonatal intensive care unit admission
Percentage of neonates required Neonatal intensive care unit admission
Measured: Immediately after birth of neonate up to discharge (approximately 30 days)
Duration in neonatal intensive care unit
Mean duration in neonatal intensive care unit in days
Measured: Through neonatal intensive care unit stay up to discharge (approximately 30 days)
Neonatal complications
Percentage of neonates with complications
Measured: Immediately after birth up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Oct 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All women with twin pregnancies will be screened for suitability via measurement of the cervical length at 20 to 24 weeks gestation. Those with a cervical length of 30mm or less will be recruited into the study.
- Masking
- None (open label)
- Enrolment
- 142 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342585
- Sponsor's protocol ID
- JEP-2020-065
- Other IDs
- DIP-2019-028
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth
- ClinicalTrials.gov ID
- NCT04342585
- Acronym / sponsor ID
- JEP-2020-065
- Conditions
- Preterm Birth
- Keywords
- twin, vaginal pessary, vaginal progestogen, short cervix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 13 Apr 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.
A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.
Detailed description
This is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. Two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All women with twin pregnancies will be screened for suitability via measurement of the cervical length at 20 to 24 weeks gestation. Those with a cervical length of 30mm or less will be recruited into the study.
| Arm | Type | Receives |
|---|---|---|
| Vaginal progestogen | Active comparator | Drug: Micronised vaginal progesterone200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation. |
| Vaginal pessary | Active comparator | Device: Vaginal pessaryVaginal pessary with an internal diameter size of 32 or 35 mm will be inserted at the time of recruitment and kept until 34 weeks gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all twin pregnancies
- cervical length less than 30mm
Key exclusion criteria (8 listed)
- Twin to twin transfusion syndrome
- Stillbirth
- congenital anomaly in one of the fetuses
- previous cervical trauma or surgery
- cervical cerclage in current pregnancy
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 |
|---|---|---|
| Micronised vaginal progesteroneAlso: UtrogestanA diary will be given to participants to ensure compliance. | Drug | Vaginal progestogen |
| Vaginal pessaryAlso: Arabin pessaryThe internal diameter size will be decided based on the clinical assessment of the cervix. | Device | Vaginal pessary |
Primary outcome
Spontaneous preterm birth
Time frame: Through study completion up to 37 weeks
Mean gestational age at delivery in weeks
25 secondary outcomes
Maternal age
Time frame: Pre-intervention
Race
Time frame: Pre-intervention
Maternal body mass index
Time frame: Pre-intervention
Parity
Time frame: Pre-intervention
Type of twin pregnancy
Time frame: Pre-intervention
Type of conception
Time frame: Pre-intervention
Gestational age at recruitment
Time frame: Pre-intervention
Gestational age at commencement of treatment
Time frame: Pre-intervention
Cervical length before commencement of treatment
Time frame: Pre-intervention
Vaginal infection
Time frame: Pre-intervention
Previous miscarriages
Time frame: Pre-intervention
Pre-existing medical disorders
Time frame: Pre-intervention
Previous spontaneous preterm birth
Time frame: Pre-intervention
Antenatal complications
Time frame: Through study completion up to 37 weeks
Fetal complications
Time frame: Through study completion up to 37 weeks
Mode of delivery
Time frame: Through study completion up to 37 weeks
Intrapartum complications
Time frame: Throughout labour up to delivery of the neonate
Postpartum complications
Time frame: Through delivery of neonate up to 42 days after delivery
Total blood loss
Time frame: Through delivery of neonate up to 42 days after delivery
Birth weight
Time frame: Immediately after birth of neonate
Apgar score
Time frame: Immediately after birth of neonate
Anthropometry assessment of neonates
Time frame: Immediately after birth of neonate
Neonatal intensive care unit admission
Time frame: Immediately after birth of neonate up to discharge (approximately 30 days)
Duration in neonatal intensive care unit
Time frame: Through neonatal intensive care unit stay up to discharge (approximately 30 days)
Neonatal complications
Time frame: Immediately after birth up to 30 days
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 23 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micronised vaginal progesterone and Vaginal pessary in people with 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 2 inclusion and 8 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 23 Jan 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Spontaneous preterm birth (time frame: Through study completion up to 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.