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Completed

NCT Number: NCT04295187

Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 month–66 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Babies died after the perinatal period.

Treatment and study plan

Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3

Other

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 Health

Other

Physical development and General health examination

Developmental Red flags

Other

Developmental Red flags Questionnaires

Primary outcomes

  1. 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.

Secondary outcomes

  1. Score of Communication

    Time frame: Up to 66 months after birth

    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

  2. Score of Gross motor

    Time frame: Up to 66 months after birth

    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

  3. Score of Fine motor

    Time frame: Up to 66 months after birth

    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

  4. Score of Problem solving

    Time frame: Up to 66 months after birth

    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

  5. Score of Personal-Social

    Time frame: Up to 66 months after birth

    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

  6. The rate of children who have at least one red flag sign

    Time frame: From 2 to 5.5 years after birth

    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

  7. Duration of breast-feeding

    Time frame: Up to 24 months after birth

    Duration of breast-feeding

  8. Infant age at which weaning starts

    Time frame: Up to 24 months after birth

    Infant age at which weaning starts

  9. Name of diseases that lead to hospital admission

    Time frame: Up to 66 months after birth

    Name of diseases that lead to hospital admission

  10. Number of hospital admission

    Time frame: Up to 66 months after birth

    Number of hospital admission

  11. Weight

    Time frame: Through study completion, an average of 1.5 months

    Weight on the examination date

  12. Height

    Time frame: Through study completion, an average of 1.5 months

    Height on the examination date

Other outcomes

  1. The rate of long-term illness and chronic conditions

    Time frame: Up to 66 months after birth

    Any long-term illness and chronic condition appears in a child

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

Physical, Mental and Motor Development of Children Born to Mothers Treated With Pessary or Progesterone Supplement for Preventing Preterm Birth

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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