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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Speculum Exams

    Procedure/Surgery

    Same as arm

  • Digital Exams

    Procedure/Surgery

    Same as arm

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Speculum ExamsActive comparator 1 intervention
Group B: Digital ExamsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pregnancy latency

time from admission to delivery

Time frame
up to 10 weeks

Secondary outcomes

1

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

Time frame
Prior to delivery
2

Endomyometritis

Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness

Time frame
Within 2 weeks of delivery
3

Maternal sepsis

Defined as bacteremia with evidence of organ dysfunction

Time frame
Within 2 weeks of delivery
4

Maternal wound infections

As diagnosed by the clinicians

Time frame
Within 2 weeks of delivery

Other outcomes

Sponsors and contacts

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