Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children

NCT04295187 | Completed

• 1 other identifier: CS/BVMĐ/20/03
• Study Type: observational
• Target: 529
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Pesary; Progesterone; ASQ-3; Health of children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Score of Communication

  Up to 66 months after birth

• Score of Gross motor

  Up to 66 months after birth

• Score of Fine motor

  Up to 66 months after birth

• Score of Problem solving

  Up to 66 months after birth

• Score of Personal-Social

  Up to 66 months after birth

Other Outcomes (1)

• The rate of long-term illness and chronic conditions

  Up to 66 months after birth

Study Arms (2)

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; Other: Physical development and General Health; Other: Developmental Red flags

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; Other: Physical development and General Health; Other: Developmental Red flags

Interventions

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.

Cervical pessary; Vaginal Progesterone

Physical development and General Health OTHER

Physical development and General health examination

Cervical pessary; Vaginal Progesterone

Developmental Red flags OTHER

Developmental Red flags Questionnaires

Cervical pessary; Vaginal Progesterone

Eligibility Criteria

• Age: 1 Month - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• Babies died after the perinatal period.

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 30741812 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Health Status

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Dang Q Vinh, MD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: March 6, 2020
• Primary Completion: July 15, 2020
• Study Completion: December 9, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)