Digital vs. Speculum Exams for PPROM
- Conditions
- PPROM
- Interventions
- Procedure: Speculum ExamsProcedure: Digital Exams
- Registration Number
- NCT05773014
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
After preterm prelabor rupture of membranes (PPROM)\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 86
- 22 weeks 0 days gestation to 33 weeks 5 days gestation
- Clinical or laboratory confirmation of PPROM
- At least 8 hours after rupture event
- English speaking
Notably, for patients <25 weeks, approach for enrollment will be deferred until after the patient has discussed their desires for fetal resuscitation with the care team and are at a gestational age where they would desire this resuscitation.
- Contraindications to digital examination
- COVID-19 positive on admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Speculum Exams Speculum Exams If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a sterile speculum exam. A sterile speculum with lubricating jelly will be inserted into the patient's vagina to visualize the cervix and visually estimate cervical dilation and effacement. Digital Exams Digital Exams If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a digital exam. The provider will wear sterile gloves with lubricating jelly and will palpate the cervix to assess cervical dilation, effacement, and station.
- Primary Outcome Measures
Name Time Method Pregnancy latency up to 10 weeks time from admission to delivery
- Secondary Outcome Measures
Name Time Method Maternal sepsis Within 2 weeks of delivery Defined as bacteremia with evidence of organ dysfunction
Maternal intensive care unit (ICU) admission Within 2 weeks of delivery transfer to ICU or readmission to ICU
Composite neonatal morbidity 28 days of life Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise
Need for respiratory support 28 days of life One or more of the following: Continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 continuous hours, extracorporeal membrane oxygenation (ECMO), or mechanical ventilation
Neonatal sepsis at >72 hours of life 28 days of life must be confirmed on blood culture
Hypoxic ischemic encephalopathy 28 days of life As diagnosed by NICU team
Patient satisfaction with exams At delivery Survey regarding their experience with cervical exams
Maternal chorioamnionitis Prior to delivery Per criteria of American College of Obstetricians and Gynecologists (ACOG): includes fever greater than or equal to 100.4 degrees Farenheit plus an additional sign such as fundal tenderness, white blood cell count \>15, purulent vaginal discharge, fetal tachycardia, or placental culture with finding of chorioamnionitis. Suspected chorioamnionitis can also be diagnosed with isolated fever \>102.2 degrees Fahrenheit
Endomyometritis Within 2 weeks of delivery Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness
Length of neonatal intensive care unit (NICU) admission Up to 1 year From delivery until discharge from the NICU
Neonatal death During NICU admission, up to 1 year As documented in the EMR
Maternal wound infections Within 2 weeks of delivery As diagnosed by the clinicians
Neonatal pneumonia 28 days of life As diagnosed by NICU team
Neonatal sepsis at <72 hours of life Within 72 hours of birth must be confirmed on blood culture
Maternal death Within 2 weeks postpartum Death of mother
Neonatal intraventricular hemorrhage (IVH) 28 days of life Seen on head ultrasound
Necrotizing enterocolitis (NEC) 28 days of life As diagnosed by NICU team
Trial Locations
- Locations (1)
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States