PPP trial

JRCT ID: jRCTs041210014

Registered date:28/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spontaneous preterm birth (22 - 36 weeks of gestation)
• Date of first enrollment: 26/05/2021
• Target sample size: 345
• Study type: Interventional
• Intervention(s): Single arm:The study medicine (6 tablets(3g) of Bio-three combination OD tablet /day) will be started in 3 divided doses between 10 weeks 0 day and 14 weeks 6 days of pregnancy. Treatment will be continued until delivery or 36 weeks and 6 days of gestation.

Outcome(s)

• Primary Outcome: The presence of spontaneous preterm delivery less than 37 weeks.

Secondary Outcome

1.The presence by which pregnancy for less than 34 weeks is spontaneous preterm delivery.
2.The presence by which pregnancy for less than 28 weeks is repeated spontaneous preterm delivery.
3.The ratio of the butyric acid bacteria including the inside Clostridium genus of the intestinal bacteria (NGS).
4.The rate of bacterial vaginosis (the value in Nugent score).
5.The rate of cases with short cervix (<25mm) at 21-24 weeks.
6.The presence of histological chorioamnionitis, funisitis.
7.The presence of stillbirth.
8.The presence of neonatal morbidity [delivery weeks, birth weight, NICU hospitalization, neonatal death, serious complications (RDS, PVL, CLD according to the type, IVH according to the type, NEC)].
9.Constipation evaluated by BFS and CSS.
10.Medical expenses.
11.Medication.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 43age old
• Gender: Female

Include criteria

1.Pregnant women less than 14 weeks pregnant with a history of spontaneous preterm birth (22 - 36 weeks of gestation).
2.Pregnant women aged 20 to 43 at the time of consent.(After April, 2022, pregnant women aged 18 to 43)
3.Pregnant women with written consent.

Exclude criteria

(1)Multiple pregnancy
(2)pregnant women with severe physical disability
(3)pregnant women with allergy of biothree
(4)pregnant women who had used biothree within 2 weeks
(5)pregnant women with a history of conization
(6)pregnant women with uterine anomaly
(7)pregnant women with cervical polyp and apparent genital bleeding less than 10 weeks
(8)pregnant women with subchorionic hematoma and apparent genital bleeding
(9)pregnant women who have used steroid
(10)pregnant women with diabetes
(11)pregnant women with autoimmune disease
(12)pregnant women complicated malignancy
(13)pregnant women with fetal anomaly
(14)pregnant women who take part in another clinical study
(15)pregnant women who is judged to be inappropriate for this study by principal investivator

Related Information

• Primary Sponsor: Yoneda Satoshi
• Secondary Sponsor: Saito Shigeru
• Source(s) of Monetary Support: TOA BIOPHARMA CO.,LTD