Digital vs. Speculum Exams for PPROM

ConditionPPROM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWashington University School of Medicine

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

Qualifiers

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

Treatments tested in this trial

  • Speculum Exams
  • Digital Exams

Treatment groups

86 Participants
are divided into 2 treatment groups