PPROM
Conditions
Keywords
PPROM, speculum exam, preterm birth, preterm prelabor rupture of membranes
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.
Interventions
PROCEDURESpeculum Exams
Same as arm
PROCEDUREDigital Exams
Same as arm
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Contraindications to digital examination * COVID-19 positive on admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy latency | up to 10 weeks | time from admission to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal sepsis | Within 2 weeks of delivery | Defined as bacteremia with evidence of organ dysfunction |
| 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 |
| Maternal intensive care unit (ICU) admission | Within 2 weeks of delivery | transfer to ICU or readmission to ICU |
| Maternal death | Within 2 weeks postpartum | Death of mother |
| Composite neonatal morbidity | 28 days of life | Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise |
| Length of neonatal intensive care unit (NICU) admission | Up to 1 year | From delivery until discharge from the NICU |
| 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 |
| Maternal wound infections | Within 2 weeks of delivery | As diagnosed by the clinicians |
| Neonatal sepsis at >72 hours of life | 28 days of life | must be confirmed on blood culture |
| Neonatal intraventricular hemorrhage (IVH) | 28 days of life | Seen on head ultrasound |
| Necrotizing enterocolitis (NEC) | 28 days of life | As diagnosed by NICU team |
| Hypoxic ischemic encephalopathy | 28 days of life | As diagnosed by NICU team |
| Neonatal pneumonia | 28 days of life | As diagnosed by NICU team |
| Neonatal death | During NICU admission, up to 1 year | As documented in the EMR |
| Patient satisfaction with exams | At delivery | Survey regarding their experience with cervical exams |
| Neonatal sepsis at <72 hours of life | Within 72 hours of birth | must be confirmed on blood culture |
Countries
United States
Contacts
Primary ContactNandini Raghuraman, MD
Backup ContactJaime Strickland
Outcome results
None listed