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Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy

ConditionHigh Risk Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQH Medical Technology Ltd.

About this trial

Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women with a pregnancy and a history of at least one spontaneous preterm birth before 34+0 weeks and/or a history of late abortion

12+0 -18+0 weeks of gestation

Minimal age of 18 years

Informed consent signature

Disqualifiers

The previous preterm delivery is iatrogenic proterm labor

Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)

The pregnant woman with severe cervical erosion, cervical polyp, hemorrhage and the doctors think she could not use cerclage pessary

The pregnant woman with uterine cervicitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progesterone

    Drug

    progeaterone:Utrogestan is one of the normal drugs in China to prevent spontaneous preterm birth, the Utrogestan used in this study is from Laboratories Besins International.

  • pessary

    Device

    pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: pessaryExperimental treatment 1 intervention
Group B: ProgesteroneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Child's birth and survival（rate）

Child's birth and survival

Time frame
34+0 weeks

Secondary outcomes

1

Time to birth of Offspring（gestational weeks）

* Preterm birth before 37 weeks: rate of delivery before 36+6 weeks * Preterm birth before 34 weeks: rate of delivery before 33+6 weeks * Preterm birth before 32 weeks: rate of delivery before 31+6 weeks * Preterm birth before 30 weeks: rate of delivery before 29+6 weeks * Preterm birth before 28 weeks: rate of delivery before 27+6 weeks

Time frame
before 37+0 weeks
2

Birth weight of Offspring(g)

median weight (g) of the newborns at birth

Time frame
before 37+0 weeks
3

Fetal or neonatal death （rate）

rate of intrauterine demise or neonatal death during the first 24 hours

Time frame
before 37+0 weeks
4

Neonatal morbidity （rate）

rate of major adverse neonatal outcomes before discharge from the hospital： * Intraventricular Haemorrhage (IVH): grades III-IV * Retinopathy of prematurity * Respiratory Distress Syndrome (RDS): grades II-IV * Need for ventilation \> 72 h * Necrotising enterocolitis * Proven or suspected sepsis, antibiotics (\>5 days) * Need (Duration in days) for neonatal special care (NICU)

Time frame
before 37+0 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

QH Medical Technology Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: