Comparing digital and speculum exams for preterm prelabor rupture of membranes
Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05773014 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals between 22 and 33 weeks of gestation who have clinically or laboratory-confirmed PPROM.
Not a fit: Patients with contraindications to digital examination or those who are COVID-19 positive upon admission may not benefit from this study.
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 performed: Previous studies have raised concerns about the impact of examination methods on pregnancy latency, but this specific randomized non-inferiority trial approach is novel.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- Barnes Jewish Hospital — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Nandini Raghuraman, MD
- Email: nraghuraman@wustl.edu
- Phone: 3142732939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.