Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags

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 Type: Observational
• Enrollment (Actual): 529

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Mỹ Đức Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; 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.; Other: Physical development and General Health; Physical development and General health examination; Other: Developmental Red flags; Developmental Red flags Questionnaires
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.	Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; 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.; Other: Physical development and General Health; Physical development and General health examination; Other: Developmental Red flags; Developmental Red flags Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 66 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of breast-feeding	Duration of breast-feeding	Up to 24 months after birth
Infant age at which weaning starts	Infant age at which weaning starts	Up to 24 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	Up to 66 months after birth
Name of diseases that lead to hospital admission	Name of diseases that lead to hospital admission	Up to 66 months after birth
Number of hospital admission	Number of hospital admission	Up to 66 months after birth
Weight	Weight on the examination date	Through study completion, an average of 1.5 months
Height	Height on the examination date	Through study completion, an average of 1.5 months
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	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	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	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	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	From 2 to 5.5 years after birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of long-term illness and chronic conditions	Any long-term illness and chronic condition appears in a child	Up to 66 months after birth

Collaborators and Investigators

• Sponsor: Mỹ Đức Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2020
• Primary Completion (ACTUAL): July 15, 2020
• Study Completion (ACTUAL): December 9, 2020

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (ACTUAL): March 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Progesterone; ASQ-3; Health of children; Pesary
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: CS/BVMĐ/20/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No