ACOG guidance on Prelabor Rupture of Membranes (PROM) addresses current literature especially related to management of late preterm PROM (34w0d to 36w6d). Following appropriate counseling, expectant management or delivery is appropriate. The use of ‘prelabor’ is in keeping with reVITALize terminology (see ‘Related ObG Topics’ below) and is defined as the ‘spontaneous rupture of membranes that occurs before the onset of labor’.
Note: In August 2018, the FDA sent a letter to health providers to be aware of rupture of membranes (ROM) test limitations, due to reports of adverse events. The FDA letter states that “health care providers may be over-relying on ROM test results when making critical patient management decisions, despite labeling instructions warning against this practice.” To promote awareness and aid in the proper use of the ROM test, the FDA letter states
The following limitations are typically stated in ROM device labeling
- A negative result does not assure the absence of membrane rupture
- False negatives may result if the amniotic sac has resealed or the position of the fetus has obstructed the rupture
- The presence of blood, meconium, anti-fungal creams or suppositories, baby powder, baby oil, or the use of lubricant with a vaginal exam may interfere with the device
- The test may not be accurate if sample collection and testing occurs after the timeframe recommended by the manufacturer
- To help protect patients and reduce the chance of adverse events, ROM tests should be part of an overall clinical assessment, which may include physical examination of the patient and testing to detect leaking amniotic fluid
Clinical Considerations
Management
Note: There are multiple regimens in use | There is no evidence to support a single optimal regimen for latency antibiotics
Care should be individualized through shred decision making, and expectant management should not extend beyond 37 0/7 weeks of gestation
Outside the scenario of unknown GBS status, latency antibiotics are not appropriate in this setting
ACOG Practice Bulletin 217: Prelabor Rupture of Membranes
ACOG Practice Bulletin 831: Medically Indicated Late-Preterm and Early-Term Deliveries
FDA: Risks Associated with Use of Rupture of Membranes Tests – Letter to Health Care Providers
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