Clinical trial NCT04295187: Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children
Official title: Physical, Mental and Motor Development of Children Born to Mothers Treated With Pessary or Progesterone Supplement for Preventing Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Pesary
Progesterone
ASQ-3
Health of children
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 529
Sex: ALL
Minimum age (years): 1
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
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)

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The average total ASQ-3 score
timeFrame: Up to 66 months after birth
Secondary outcomes:
measure: Score of Communication
timeFrame: Up to 66 months after birth
measure: Score of Gross motor
timeFrame: Up to 66 months after birth
measure: Score of Fine motor
timeFrame: Up to 66 months after birth
measure: Score of Problem solving
timeFrame: Up to 66 months after birth
measure: Score of Personal-Social
timeFrame: Up to 66 months after birth
measure: The rate of children who have at least one red flag sign
timeFrame: From 2 to 5.5 years after birth
measure: Duration of breast-feeding
timeFrame: Up to 24 months after birth
measure: Infant age at which weaning starts
timeFrame: Up to 24 months after birth
measure: Name of diseases that lead to hospital admission
timeFrame: Up to 66 months after birth
measure: Number of hospital admission
timeFrame: Up to 66 months after birth
measure: Weight
timeFrame: Through study completion, an average of 1.5 months
measure: Height
timeFrame: Through study completion, an average of 1.5 months
Other outcomes:
measure: The rate of long-term illness and chronic conditions
timeFrame: Up to 66 months after birth
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Mỹ Đức Hospital
Study officials:
affiliation: Mỹ Đức Hospital
name: Dang Q Vinh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.