About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Contraindications to digital examination
COVID-19 positive on admission
Trial design
Parallel
Treatments tested in this trial
Speculum Exams
Procedure/SurgerySame as arm
Digital Exams
Procedure/SurgerySame as arm
Treatment groups
Trial outcomes
Primary outcomes
Pregnancy latency
time from admission to delivery
Secondary outcomes
Maternal chorioamnionitis
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
Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness
Maternal sepsis
Defined as bacteremia with evidence of organ dysfunction
Maternal wound infections
As diagnosed by the clinicians
Sponsors and contacts
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