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.
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 Type
OBSERVATIONAL
Enrollment
529
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
Mỹ Đức Hospital
Ho Chi Minh City, Vietnam
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.
Time frame: Up to 66 months after birth
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: From 2 to 5.5 years after birth
Duration of breast-feeding
Duration of breast-feeding
Time frame: Up to 24 months after birth
Infant age at which weaning starts
Infant age at which weaning starts
Time frame: Up to 24 months after birth
Name of diseases that lead to hospital admission
Name of diseases that lead to hospital admission
Time frame: Up to 66 months after birth
Number of hospital admission
Number of hospital admission
Time frame: Up to 66 months after birth
Weight
Weight on the examination date
Time frame: Through study completion, an average of 1.5 months
Height
Height on the examination date
Time frame: Through study completion, an average of 1.5 months