A Randomized Multicenter Clinical Trial of the Novocuff Cervical Control System Vs. Standard of Care for the Treatment of Patients with Preterm Premature Rupture of Membranes (Pprom)
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 premature 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
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
1. Pregnant patient with singleton gestation
2. Per ACOG Practice Bulletin 217, diagnosis of PPROM confirmed by
conventional clinical assessment (visualization of amniotic fluid passing from the
cervical canal and pooling in the vagina, a simple pH test of vaginal fluid, or
ferning of dried vaginal fluid identified under microscopic evaluation. In equivocal
cases, additional tests may aid in diagnosis including ultrasonographic
examination of amniotic fluid volume, or commercially available amniotic protein
tests with reported high sensitivity for PPROM.)
3. PPROM onset at 24 and 0/7 to 32 and 6/7 weeks gestation
4. ≥ 24 hours from onset of PPROM to randomization
5. ≤ 3 days between onset of PPROM (onset of PPROM counted as Day 0) and
randomization (and placement of device in Novocuff group)
6. Patient deemed appropriate for expectant management according to ACOG
Practice Bulletin 217
7. Cervical dilation 8. Age 18 years or older at time of consent
9. Willing and able to sign written informed consent
10. Willing to remain hospitalized for duration of study
11. Willing to complete both maternal and neonatal study follow up
Exclusion Criteria:
1. Multiple gestation during this pregnancy
2. Any signs of preterm labor during this hospital admission, prior to randomization
(e.g., persistent labor characterized by regular painful contractions with cervical
change and/or cervix visually greater than 1 cm by time of randomization)
3. Known maternal or fetal contraindication to expectant management
4. Per ACOG Committee Opinion 712, clinically suspected intraamniotic infection
(suspected intraamniotic infection is defined as having maternal temperature ≥
102.2 o
F (39o C) or having maternal temperature between 100.4 – 102.2 o F (38 -
39o C) and one additional clinical risk factor present (maternal leukocytosis,
purulent cervical drainage, or fetal tachycardia)
5. Maternal sepsis during this pregnancy
6. Clinically diagnosed bacterial vaginosis or a sexually transmitted infection (i.e.,
chlamydia, gonorrhea, trichomonas, etc. diagnosed by laboratory exam) without
initiation of treatment (if at least one dose of treatment has been taken,
enrollment is allowed)
7. Diagnosis of syphilis during this pregnancy with reactive rapid plasma reagin or
syphilis antibodies with no, or inadequate (as judged by investigator) treatment
8. Diagnosis of HIV, unless treated and current viral load is undetectable
9. Known severely shortened cervix (10. Known abnormal gynecologic anatomy at the cervix (e.g., cervical leiomyoma)
11. Cerclage during this pregnancy (at any time in this pregnancy, even if removed)
12. Prior cervical surgery that causes cervical anatomical distortion
13. Current known diagnosis of cervical cancer
14. Known allergy to silicone
15. Known allergy to both vaginal prep options (chlorhexidine or povidone iodine)
16. Contraindication to any of the latency antibiotics used as standard of care in the
treatment of PPROM (unless standard replacement option is available for use)
17. Currently taking immunosuppressants (not including antenatal corticosteroids)
18. Complete or incomplete placenta abnormality (i.e., previa, accreta, increta,
abrupted)
19. Clinical diagnosis of significant vaginal bleeding that would contraindicate the
patient to expectant management of PPROM
20. Clinical diagnosis of non-reassuring fetal status that would contraindicate the
patient to expectant management of PPROM
21. Clinical diagnosis of a major structural fetal anomaly or genetic disorder that
would contraindicate the patient to expectant management of PPROM
22. PPROM associated with an amniocentesis procedure
23. Enrollment in another interventional clinical trial that may impact the primary or
secondary endpoints of this study
24. Prior enrollment in this trial (for a prior pregnancy)
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.
