Preterm BirthNCT04295187
Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children
An observational study of Preterm Birth, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
To give strong recommendations on the efficacy and safety of vaginal progesterone versus cervical cerclage, we conduct this study to investigate the physical and mental development of children from vaginal progesterone versus cervical cerclage. Read more about this study
- Who is it for?
- Ages 1 month to 66 months
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health and Developmental Red flags
- How many people
- 529 participants
- Where
- 1 siteVietnam
- Study dates
- 6 Mar 2020to 9 Dec 2020
- 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 1 month to 66 months
- All sexes
- No healthy volunteers
- Child
Study population: Live babies born following the pessary versus vaginal progesterone in women with a twin pregnancy and a cervix <38 mm study (NCT02623881)
Who may be able to join
- Live babies born from The pessary versus vaginal progesterone in women with a twin pregnancy and a cervix <38 mm study (NCT02623881)
- Parents agree to participate in the study.
Who cannot join
- Babies died after the perinatal period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical, Mental and Motor Development of Children Born to Mothers Treated With Pessary or Progesterone Supplement for Preventing Preterm Birth
To give strong recommendations on the efficacy and safety of vaginal progesterone versus cervical cerclage, we conduct this study to investigate the physical and mental development of children from vaginal progesterone versus cervical cerclage. Based on our research (Dang et al., 2019), the twin pregnancies with cervical lengths less than 38mm were randomly assigned to receive vaginal progesterone or cervical cerclage, which leads to the similarity in characteristics of these two groups. Hence, the result of analyzing these offsprings would be preciously valuable.
Read the detailed description
Preterm birth (PB) is the leading cause of neonatal morbidity and mortality. Twin pregnancies and short cervical length are two high-risk factors of PB. Generally, in singleton pregnancies with short cervical length below 25 mm, or with a history of preterm birth, preventive measures of PB are vaginal progesterone and cervical cerclage. The cervical pessary is also being investigated for effectiveness in PB prevention in different populations. However, the effective preventive methods for PB has not been identified up to now in twin pregnancies with short cervical length.
In our research, the results showed that the preterm birth rate before 34 weeks in the cervical pessary group was lower than the progesterone group (16% vs 22%, RR 0.73; 95% CI 0.46 - 1.18). The perinatal outcomes were also better in the cervical pessary group than in the progesterone group (19% vs 27%, RR 0.70; 95% CI 0.43 - 0.93). The cost of the cervical pessary method was also significantly lower than the vaginal progesterone method cost. Pessary insertion was also more convenient since it was only inserted once during pregnancy, compared to daily vaginal progesterone. Therefore, the cervical pessary may be an appropriate option for preventing preterm birth in twin pregnancies with a short cervix.
However, besides these short-term outcomes, we need to pay more attention to the longer-term issues of both mothers and infants. Some evidence up to now has demonstrated that both these two methods are safe with no impact on physical, mental, and motor development of children up to 3 years old and even in older children. However, such evidence is still rare. Also, there hasn't been any study evaluating the impact, if any, of these two PB preventive methods.
- Conditions
- Preterm Birth
- Being tested
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health, Developmental Red flags
- Keywords
- Pesary, Progesterone, ASQ-3, Health of children
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Other
Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
Physical development and General HealthOther
Physical development and General health examination
Developmental Red flagsOther
Developmental Red flags Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Cervical pessary | Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort. Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags | |
| Vaginal Progesterone | Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort. Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average total ASQ-3 score
ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
ASQ-3 average = average score of 5 aspects.
Measured: Up to 66 months after birth
Secondary outcomes (12)
Score of Communication
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold
Measured: Up to 66 months after birth
Score of Gross motor
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold
Measured: Up to 66 months after birth
Score of Fine motor
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold
Measured: Up to 66 months after birth
Score of Problem solving
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold
Measured: Up to 66 months after birth
Score of Personal-Social
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold
Measured: Up to 66 months after birth
The rate of children who have at least one red flag sign
He or she has at least one red flag sign by age
From 2 to < 3 year-old:
Has very unclear speech Doesn't understand simple instruction • Doesn't speak in sentences Doesn't make eye contact Loses skills he/she once had
From 3 to < 4 year-old:
Can't jump in place Doesn't play pretend or make-believe • Speaks unclearly Can't retell a favorite story Doesn't use "me" and "you" correctly Loses skills he/she once had
From 4 to < 5.5 year-old:
Is easily distracted, has trouble focusing on one activity for more than 5 minutes • Doesn't talk about daily activities or experiences Shows extreme behavior Loses skills he/she once had
Measured: From 2 to 5.5 years after birth
Duration of breast-feeding
Duration of breast-feeding
Measured: Up to 24 months after birth
Infant age at which weaning starts
Infant age at which weaning starts
Measured: Up to 24 months after birth
Name of diseases that lead to hospital admission
Name of diseases that lead to hospital admission
Measured: Up to 66 months after birth
Number of hospital admission
Number of hospital admission
Measured: Up to 66 months after birth
Weight
Weight on the examination date
Measured: Through study completion, an average of 1.5 months
Height
Height on the examination date
Measured: Through study completion, an average of 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start6 Mar 2020
- Primary completion15 Jul 2020
- Study completion9 Dec 2020
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 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dang Q Vinh, MD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295187
- Sponsor's protocol ID
- CS/BVMĐ/20/03
- Status last verified
- Feb 2021
- First submitted
- 2 Mar 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dang VQ, Nguyen LK, Pham TD, He YTN, Vu KN, Phan MTN, Le TQ, Le CH, Vuong LN, Mol BW. Pessary Compared With Vaginal Progesterone for the Prevention of Preterm Birth in Women With Twin Pregnancies and Cervical Length Less Than 38 mm: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):459-467. doi: 10.1097/AOG.0000000000003136.
PubMed 30741812
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical, Mental and Motor Development of Children Born to Mothers Treated With Pessary or Progesterone Supplement for Preventing Preterm Birth
- ClinicalTrials.gov ID
- NCT04295187
- Acronym / sponsor ID
- CS/BVMĐ/20/03
- Conditions
- Preterm Birth
- Keywords
- Pesary, Progesterone, ASQ-3, Health of children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 4 Mar 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.
To give strong recommendations on the efficacy and safety of vaginal progesterone versus cervical cerclage, we conduct this study to investigate the physical and mental development of children from vaginal progesterone versus cervical cerclage. Based on our research (Dang et al., 2019), the twin pregnancies with cervical lengths less than 38mm were randomly assigned to receive vaginal progesterone or cervical cerclage, which leads to the similarity in characteristics of these two groups. Hence, the result of analyzing these offsprings would be preciously valuable.
Detailed description
Preterm birth (PB) is the leading cause of neonatal morbidity and mortality. Twin pregnancies and short cervical length are two high-risk factors of PB. Generally, in singleton pregnancies with short cervical length below 25 mm, or with a history of preterm birth, preventive measures of PB are vaginal progesterone and cervical cerclage. The cervical pessary is also being investigated for effectiveness in PB prevention in different populations. However, the effective preventive methods for PB has not been identified up to now in twin pregnancies with short cervical length.
In our research, the results showed that the preterm birth rate before 34 weeks in the cervical pessary group was lower than the progesterone group (16% vs 22%, RR 0.73; 95% CI 0.46 - 1.18). The perinatal outcomes were also better in the cervical pessary group than in the progesterone group (19% vs 27%, RR 0.70; 95% CI 0.43 - 0.93). The cost of the cervical pessary method was also significantly lower than the vaginal progesterone method cost. Pessary insertion was also more convenient since it was only inserted once during pregnancy, compared to daily vaginal progesterone. Therefore, the cervical pessary may be an appropriate option for preventing preterm birth in twin pregnancies with a short cervix.
However, besides these short-term outcomes, we need to pay more attention to the longer-term issues of both mothers and infants. Some evidence up to now has demonstrated that both these two methods are safe with no impact on physical, mental, and motor development of children up to 3 years old and even in older children. However, such evidence is still rare. Also, there hasn't been any study evaluating the impact, if any, of these two PB preventive methods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical pessary | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Other: Physical development and General Health, Other: Developmental Red flagsCervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort. |
| Vaginal Progesterone | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Other: Physical development and General Health, Other: Developmental Red flagsVaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort. |
Who may qualify
- Ages
- 1 month to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Live babies born following the pessary versus vaginal progesterone in women with a twin pregnancy and a cervix <38 mm study (NCT02623881)
Key inclusion criteria (2 listed)
- Live babies born from The pessary versus vaginal progesterone in women with a twin pregnancy and a cervix <38 mm study (NCT02623881)
- Parents agree to participate in the study.
Key exclusion criteria (1 listed)
- Babies died after the perinatal period.
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 |
|---|---|---|
| Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones. | Other | Cervical pessary, Vaginal Progesterone |
| Physical development and General HealthPhysical development and General health examination | Other | Cervical pessary, Vaginal Progesterone |
| Developmental Red flagsDevelopmental Red flags Questionnaires | Other | Cervical pessary, Vaginal Progesterone |
Primary outcome
The average total ASQ-3 score
Time frame: Up to 66 months after birth
ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.
12 secondary outcomes
Score of Communication
Time frame: Up to 66 months after birth
Score of Gross motor
Time frame: Up to 66 months after birth
Score of Fine motor
Time frame: Up to 66 months after birth
Score of Problem solving
Time frame: Up to 66 months after birth
Score of Personal-Social
Time frame: Up to 66 months after birth
The rate of children who have at least one red flag sign
Time frame: From 2 to 5.5 years after birth
Duration of breast-feeding
Time frame: Up to 24 months after birth
Infant age at which weaning starts
Time frame: Up to 24 months after birth
Name of diseases that lead to hospital admission
Time frame: Up to 66 months after birth
Number of hospital admission
Time frame: Up to 66 months after birth
Weight
Time frame: Through study completion, an average of 1.5 months
Height
Time frame: Through study completion, an average of 1.5 months
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 Feb 2021.
- Results publication: PubMed 30741812Dang VQ, Nguyen LK, Pham TD, He YTN, Vu KN, Phan MTN, Le TQ, Le CH, Vuong LN, Mol BW. Pessary Compared With Vaginal Progesterone for the Prevention of Preterm Birth in Women With Twin Pregnancies and Cervical Length Less Than 38 mm: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):459-467. doi: 10.1097/AOG.0000000000003136.
- Individual participant dataSharing planned: No
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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.
Dang Q Vinh, MD principal investigator
Mỹ Đức Hospital
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 Preterm Birth, run by Mỹ Đức Hospital at 1 site in Vietnam.
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 1 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 Feb 2021. 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 Vietnam. 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?
The average total ASQ-3 score (time frame: Up to 66 months after birth). 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 NCT04295187, 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 Feb 2021.