A Randomized Multicenter Clinical Trial of the Novocuff Cervical Control System Vs. Standard of Care for the Treatment of Patients with Preterm Prelabor Rupture of Membranes
Study on Investigational Device for Early Water Breakage in Pregnancy
Christina M. Scifres, MD
Primary Investigator
Brief description of study
Evaluate the safety and effectiveness of the Novocuff Cervical Control System (CCS) in retaining amniotic fluid and improving latency in patients with preterm prelabor rupture of membranes (PPROM)
Detailed description of study
The Novocuff Cervical Control System™ is intended to retain amniotic fluid and extend
latency in patients with a singleton pregnancy and onset of preterm prelabor rupture of
membranes (PPROM) at 24 and 0/7 weeks to 32 and 6/7 weeks of gestation until
spontaneous labor occurs or delivery is indicated.
Subjects will be randomized 1:1 to standard of care (SOC) alone (“control group”) or
treatment with the Novocuff CCS and SOC (“Novocuff group”).
Maternal follow-up will occur at 7 days latency (from onset of PPROM), 14 days latency,
21 days latency and until delivery (as applicable) and then from delivery to discharge.
Neonatal Follow-Up
Short-term neonatal follow-up will occur until 28 days of life (or to discharge, if earlier).
Data collection will occur within short-term follow up at 72 hours, 1 week and 28 days of
life (or to discharge, if shorter).
Neonatal long-term follow-up will occur until discharge or 6 months of life, whichever is
shorter.
Duration of Study
It is expected to take 24-36 months to enroll, treat, and complete follow-up.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Preterm Premature Rupture of Membranes, Pprom, Riley
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Age: 18 years - 100 years
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Gender: All
Patients will be carefully screened to all eligibility criteria of the study. Pregnant patients singleton pregnancy and onset of PPROM between 24 and 32+6 weeks gestation who are hospitalized for expectant management may be eligible.
This study investigates the use of an investigational device to help manage preterm premature rupture of membranes (PPROM). PPROM occurs when the amniotic sac breaks before labor begins and before 37 weeks of pregnancy. The study will compare the investigational device with standard care to see if it can help keep the amniotic fluid inside and delay birth.
Participants in the study will be divided into two study arms. One arm will receive the standard care, while the other arm will receive both the investigational device and standard care. Follow-up will include checking on the mothers and their babies at different times, such as 7, 14, and 21 days after the start of PPROM, and after the baby is born until hospital discharge. This will help researchers understand how well the device works.
- Who can participate: Pregnant women aged 18 or older with a single baby and confirmed PPROM between 24 and 32 weeks of pregnancy can participate. They must be willing to stay in the hospital and complete follow-up visits.
- Study details: Participants will be randomly assigned to receive either the investigational device and standard care or standard care alone. They will remain in the hospital for monitoring and follow-up.
