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
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Among 26 studies in Preterm Premature Rupture of the Membranes with a site in United States — 7 open to participants now, 9 under way, 1 of them phase 3. Preterm Premature Rupture of the Membranes · United States.
Among the 26 studies in Preterm Premature Rupture of the Membranes with a site in United States, this one is the 5th largest by planned enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2023, is one of 8 with no phase, and was the 21st registered.
75 studies on the registry are indexed under Preterm Premature Rupture of the Membranes; 17 are open to participants now.
Browse Preterm Premature Rupture of the Membranes studies →7 of the 26 studies in Preterm Premature Rupture of the Membranes with a site in United States are open now. Recruiting first, the newest first:
Alexa Henderson · Sites in United States
Women only
Eastern Virginia Medical School · Sites in United States
Ages 18–50 · Women only
Ohio State University · Sites in United States
Ages 18+ · Women only
Christina Chianis Reed · Sites in United States
Ages 18–64 · Women only
Woman's · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Preterm Premature Rupture of the Membranes studies recruiting now, 7 (64%) set no upper age limit and 4 (36%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 3 · Phase 4 7
First in 2004; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 86 is close to the median of 95 across 49 interventional studies indexed under Preterm Premature Rupture of the Membranes.
Median enrollment 48 across the 20 interventional studies, 254 across the 6 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
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4 of 26 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,804 studies on the registry; 270 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 2 studies filed under Preterm Premature Rupture of the Membranes — fewer than ten, so there is no comparison to draw.
2 of the studies in Preterm Premature Rupture of the Membranes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06396078Ohio State UniversityImprovement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT) | 2026-12 |
| NCT05773014Washington University School of MedicineDigital vs. Speculum Exams for PPROM | 2027-03-01 |
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Among the 26 studies in Preterm Premature Rupture of the Membranes with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Mar 2023 (actual). Primary completion is estimated for Mar 2027, 47 months after the start.
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