Cervical pessary for the prevention of preterm delivery in pregnant women with a short cervix.

Cervical pessary for the prevention of preterm delivery in pregnant women with a short cervix. - STudy Of Cervical Pessary for the prevention of PreTerm Delivery (STOP PTD Trial).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015465

Enrollment

100

Registered

2015-01-01

Start date

2015-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm delivery

Interventions

Cervical pessary from 20 weeks gestation to 36 weeks 6days Conventional treatment until 36 weeks 6days

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1, Pregnant women with singleton pregnancies 2, Women with a cervical length of 25mm or less 3, Women with informed consent for participation in this trial

Exclusion criteria

Exclusion criteria: 1) Women with multiple pregnant 2) Cervical length id more than 26mm 3) Major fetal anomalies 4) Painful regular uterine contractions 5) Active vaginal bleeding 6) Ruptured membranes 7) Placenta previa 8) Cervical myoma 9) History of cone biopsy or cervical cerclage in situ 10) Other pregnant women when study doctors conclude that they are not eligible for study enrollment.

Design outcomes

Primary

Measure	Time frame
The rate of term delivery is equal or higher compare to the conventional therapy for prevention of preterm delivery.	—

Secondary

Measure	Time frame
A) Pregnancy outcome 1. Spontaneous delivery before 28 weeks 2. Spontaneous delivery before 37 weeks 3. Gestational age at delivery 4. Tocolytic treatment 5. Premature preterm rupture of membranes 6. Corticosteroid treatment for fetal maturation 7. Chorioamnionitis 8. Hospitalization 9. Vaginal discharge 10. Pessary withdrawal 11. Bleeding at delivery 12. Cervical laceration 13. Uterus rupture B) Perinatal outcome 1. Fetal death 2. Neonatal death 3. Birth weight 4. Adverse outcomes (Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis) 5. Hospitalization at NICU	—

Measure

Time frame

A) Pregnancy outcome 1. Spontaneous delivery before 28 weeks 2. Spontaneous delivery before 37 weeks 3. Gestational age at delivery 4. Tocolytic treatment 5. Premature preterm rupture of membranes 6. Corticosteroid treatment for fetal maturation 7. Chorioamnionitis 8. Hospitalization 9. Vaginal discharge 10. Pessary withdrawal 11. Bleeding at delivery 12. Cervical laceration 13. Uterus rupture B) Perinatal outcome 1. Fetal death 2. Neonatal death 3. Birth weight 4. Adverse outcomes (Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis) 5. Hospitalization at NICU

—

Countries

Japan

Contacts

Public ContactKyoko KUMAGAI

Nagoya City University Hospital Department of Obstetrics and Gynecology

kykkumagai@gmail.com0528515511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026