An interventional study of Speculum Exams and Digital Exams in PPROM, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other
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.
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:
If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a sterile speculum exam. A sterile speculum with lubricating jelly will be inserted into the patient's vagina to visualize the cervix and visually estimate cervical dilation and effacement.
Procedure: Speculum Exams
If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a digital exam. The provider will wear sterile gloves with lubricating jelly and will palpate the cervix to assess cervical dilation, effacement, and station.
Procedure: Digital Exams
Same as arm
Same as arm
Pregnancy latency
time from admission to delivery
Time frame: up to 10 weeks
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
Endomyometritis
Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness
Time frame: Within 2 weeks of delivery
Maternal sepsis
Defined as bacteremia with evidence of organ dysfunction
Time frame: Within 2 weeks of delivery
Maternal wound infections
As diagnosed by the clinicians
Time frame: Within 2 weeks of delivery
Maternal intensive care unit (ICU) admission
transfer to ICU or readmission to ICU
Time frame: Within 2 weeks of delivery
Maternal death
Death of mother
Time frame: Within 2 weeks postpartum
Composite neonatal morbidity
Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise
Time frame: 28 days of life
Length of neonatal intensive care unit (NICU) admission
From delivery until discharge from the NICU
Time frame: Up to 1 year
Need for respiratory support
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
Time frame: 28 days of life
Neonatal sepsis at <72 hours of life
must be confirmed on blood culture
Time frame: Within 72 hours of birth
Neonatal sepsis at >72 hours of life
must be confirmed on blood culture
Time frame: 28 days of life
Neonatal intraventricular hemorrhage (IVH)
Seen on head ultrasound
Time frame: 28 days of life
Necrotizing enterocolitis (NEC)
As diagnosed by NICU team
Time frame: 28 days of life
Hypoxic ischemic encephalopathy
As diagnosed by NICU team
Time frame: 28 days of life
Neonatal pneumonia
As diagnosed by NICU team
Time frame: 28 days of life
Neonatal death
As documented in the EMR
Time frame: During NICU admission, up to 1 year
Patient satisfaction with exams
Survey regarding their experience with cervical exams
Time frame: At delivery
Plan to share: Undecided
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Preterm Premature Rupture of the Membranes
Washington University School of Medicine