Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

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. 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.
    

Intervention name(s): Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Physical development and General Health; Developmental Red flags
Intervention type(s): Other; Other; Other
Intervention description(s): 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 examination; Developmental Red flags Questionnaires
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Live babies born following the pessary versus vaginal progesterone in women with a twin
        pregnancy and a cervix <38 mm study (NCT02623881)
      
Keywords: Pesary; Progesterone; ASQ-3; Health of children