Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
- Conditions
- Premature Birth
- Interventions
- Device: Arabin Pessary
- Registration Number
- NCT02357394
- Lead Sponsor
- Gene Lee, MD
- Brief Summary
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
- Detailed Description
This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 7
- singleton
- cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
- agrees to refrain from sexual intercourse
- major fetal anomalies
- painful regular uterine contractions
- active vaginal bleeding
- ruptured membranes
- evidence of chorioamnionitis or other maternal/fetal infectious morbidity
- placenta previa
- cervical cerclage in situ
- visual cervical dilation of 2 cm or greater with visible amnion/chorion
- significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device: Arabin Pessary Arabin Pessary Participants randomized to this group will receive the pessary.
- Primary Outcome Measures
Name Time Method Preterm Birth Before 37 Weeks Up to 37 weeks 0 days Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
- Secondary Outcome Measures
Name Time Method Admission to Neonatal Intensive Care Unit participants will be followed for the duration of hospital stay, up to 17 weeks after delivery Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
Total Days in the Neonatal Intensive Care Unit participants will be followed for the duration of hospital stay, up to 17 weeks after delivery Number of days a baby spends in the neonatal intensive care unit
Retinopathy of Prematurity Requiring Treatment participants will be followed for the duration of hospital stay, up to 17 weeks after delivery Number of newborn with Retinopathy of Prematurity that requires intervention.
Use of Antenatal Steroids participants will be followed for the duration of pregnancy, up to nine months Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
Vaginal Bleeding participants will be followed for the duration of pregnancy, up to nine months Number of participants who experienced bleeding from lower genital tract during antepartum period
Preterm Birth Before 34 Weeks up to 34 weeks 0 days Number of deliveries before 34 weeks 0 days of gestation
Neonatal Composite Morbidity antepartum and up to 28 days after postnatal gestational age of 36 weeks Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis
Preterm Premature Rupture of Membranes participants will be followed for the duration of pregnancy, up to nine months Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Neonatal Length of Stay participants will be followed for the duration of hospital stay, up to 17 weeks after delivery Total number of days in hospital after birth
Duration of Ventilator Support participants will be followed for the duration of hospital stay, up to 17 weeks after delivery Number of days a baby requires use of mechanical ventilation
Birthweight < 1500 Grams at time of birth, expected to be within 4 weeks of due date Number of newborns whose birthweight is less than 1500 grams
Birthweight < 2500 Grams at time of birth, expected to be within 4 weeks of due date Number of newborns whose birthweight is less than 2500 grams
Gestational Age at Delivery at time of birth, expected to be within 4 weeks of due date Number of weeks of gestation completed by time of delivery
Chorioamnionitis participants will be followed for the duration of pregnancy, up to nine months Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Cesarean Delivery at time of delivery, expected to be within 4 weeks of due date Number of participants that underwent cesarean delivery
Use of Tocolysis participants will be followed for the duration of pregnancy, up to nine months Number of participants required use of tocolytic medication
Trial Locations
- Locations (2)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States