Comparing digital and speculum exams for preterm prelabor rupture of membranes
Official title: Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Run by Washington University School of Medicine · NCT05773014 · Data updated 2026-11-12
This study is testing whether a digital exam or a speculum exam is better at helping pregnant women with early water breaking stay pregnant longer.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 86 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | March 27, 2023 |
| Main results expected | March 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT05773014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant individuals between 22 and 33 weeks of gestation who have clinically or laboratory-confirmed PPROM.
✕Probably not a fit
Patients with contraindications to digital examination or those who are COVID-19 positive upon admission may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of two different examination methods—digital exams and speculum exams—on the latency of pregnancy in patients diagnosed with preterm prelabor rupture of membranes (PPROM). Patients between 22 and 33 weeks of gestation who have confirmed PPROM will be randomly assigned to receive either type of exam to determine if one method is superior in prolonging the time before delivery. The study aims to address concerns regarding the impact of these exams on pregnancy outcomes and to provide evidence-based recommendations for clinical practice.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with PPROM, potentially extending pregnancy latency and improving neonatal outcomes.
How similar studies have gone: Previous studies have raised concerns about the impact of examination methods on pregnancy latency, but this specific randomized non-inferiority trial approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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: * Contraindications to digital examination * COVID-19 positive on admission
Where it's running
-
Barnes Jewish Hospital
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Nandini Raghuraman, MD
- Email: nraghuraman@wustl.edu
- Phone: 3142732939
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Extended azithromycin treatment in prelabor rupture of membranes at periviable gestations
This study tests whether giving extra doses of azithromycin beyond the standard antibiotics can improve outcomes for pregnant people with PPROM between 22 and 28 weeks.
-
Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy for PPROM
This study tests whether emotional freedom techniques and music therapy can help pregnant women with PPROM or PROM cope better and feel less stress.
-
Tailored IL-6–guided antibiotic and steroid treatment to delay birth after PPROM
This tests whether using an IL-6 lab result from amniotic fluid to guide antibiotics and steroids can help people with PPROM stay pregnant longer and improve outcomes for parent and baby.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.